ALENDRONIC ACID WARNINGS

Alendronic acid should be used with caution in:

patients with kidney problems, allergies, swallowing or digestive problemsincluding ulcers,

low bloodcalcium levels and/or vitamin-D deficiency, gum disease, or if you need a tooth removed.
A dental examination should be considered before you start treatment with alendronic acid if
you have cancer, are undergoing chemotherapy orradiotherapy, are taking steroids, do not receive
routine dental care, or have gum disease.
Appropriate preventative dental care, as recommended by your dentist, should be followed
during treatment with this drug.

It should not be used in:

patients with allergies to bisphosphonates or any of the other ingredients in the medicine, those with
problems or abnormalities with the oesophagus (the tube that connects your mouth with your
stomach) such as narrowing or difficulty swallowing, patients who cannot stand or sit upright for at
least 30 minutes, those with hypocalcaemia (low blood calcium levels), or women who
are pregnant or who are breast-feeding.

Also see list of precautions and interactions.

Alendronic acid is used to treat osteoporosis.

It is a type of drug known as a bisphosphonate.

It is used to prevent bone loss in women after they have been through themenopause, and bone loss
in men and in people taking steroids.

In general this drug is used to prevent bone loss in post-menopausal women, men and steroid users.
It is also used to help rebuild bone and reduce the risk of spine and hip fractures.

Benefits of being on this drug can include an increase in bone density and a decrease in likelihood of
fractures.

Listed below are the typical uses of alendronic acid.

Treatment of osteoporosis in post-menopausal women to prevent fractures

Treatment of osteoporosis in men to prevent fractures
Prevention and treatment of corticosteroid-induced osteoporosis and prevention of bone loss in
post-menopausal women considered at risk of developing osteoporosis.
HOW TO USE/TAKE

How often do I take it?

Alendronic acid can be taken once a day or once a week, depending on the dose required.
To help the tablet reach your stomach quickly and reduce any possible irritation you should:-
take your medication first thing in the morning, before any other food or drink with a full glass of plain
water only (not less than 200ml or 7 fl. oz). You should not take your tablet with mineral water,coffee,
tea, fruit juice, or milk. Do not chew the tablet, or allow it to dissolve in your mouth.Stay fully upright
after taking alendronic acid (sit, stand or walk) for at least 30 minutes. Do not lie down until after you
have eaten your first food of the day.
 Alendronic acid is only effective if it is taken when your stomach is empty, so do not have any
food, drink, or any other medications, including antacids, calciumsupplements and vitamins until at
least 30 minutes after taking alendronic acid.
Do not take alendronic acid at bedtime or before getting up for the day.
Use this medication regularly or for duration of prescription in order to get the most benefit
from it.
Remember to use it at the same time each day/week - unless specifically told otherwise by
your doctor.
Certain medical conditions may require different dosage instructions as directed by your
doctor.

What dose?

Dosage is based on your age, gender, medical condition, response to therapy, and use of
certain interacting medicines.

Do I need to avoid anything?

There have been side effects reported with alendronic acid that may affect the ability to drive or
operate machinery (e.g. blurred vision, dizziness, severe muscle, joint or bone pain). If affected do
not drive or operate machinery. You should avoid eating or drinking at the same time as taking your
medicine. Consult your doctor or pharmacist for more details.

When can I stop?

It is important to continue taking this medication even if you feel well, unless your doctor tells
you to stop.
ALENDRONIC ACID SIDE EFFECTS
Heartburn (a burning feeling in the chest, behind the breastbone or gullet)
Difficulty swallowing
Pain upon swallowing
Ulceration of the oesophagus (the tube that connects your mouth with your stomach)
Chest pain
Muscle, joint and back pain
Bone, muscle and/or joint pain
Stomach pain
Uncomfortable feeling in the stomach or belching after eating
Constipation
Full or bloated feeling in the stomach
Diarrhoea
Flatulence
Headache
Feeling sick (nausea)
Vomiting
Irritation or inflammation of the oesophagus or stomach
Black or tar-like stools
Rash
 Itching
Redness of the skin.

If any of these persist or you consider them severe then contact doctor or pharmacist.

Tell your doctor immediately if you develop any of the following symptoms: difficulty and/or pain when
swallowing, pain behind the breastbone or new or worsened heartburn .

Remember that your doctor has prescribed this medication because he or she has judged that the
benefit to you is greater than the risk of side effects. Many people using this medication do not have
serious side effects.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs.
Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the
face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact
your doctor or pharmacist.

The Yellow Card Scheme allows you to report suspected side effects from any type of medicine
(which includes vaccines, herbals and over the counter medicines) that you are taking. It is run by the
medicines safety watchdog called the Medicines and Healthcare products Regulatory agency
(MHRA). Please report any suspected side effect on the Yellow Card Scheme website.

ALENDRONIC ACID PRECAUTIONS

Before taking alendronic acid, tell your doctor or pharmacist if you are allergic to it; or to other
bisphosphonates; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this
medicine, consult your doctor or pharmacist if you have: allergies to bisphosphonates or any of the
other ingredients, problems or abnormalities with the oesophagus (the tube that connects your mouth
with your stomach) such as narrowing or difficulty swallowing, if you cannot stand or sit upright for at
least 30 minutes, have low blood calcium levels, or if you are pregnant or breastfeeding.

Before using this medication, tell your doctor or pharmacist your medical history, especially any of the
following: any kidney problems, allergies, swallowing or digestive problems including ulcers, low
blood calcium levels and/or a vitamin-D deficiency, gum disease, or if you need a tooth removed.

A dental examination should be considered before you start treatment with alendronic acid if you
have cancer, are undergoing chemotherapy or radiotherapy, are taking steroids, do not receive
routine dental care, or have gum disease.

Before having surgery, tell your doctor or dentist that you are taking this medication.

Alcohol intake is not known to affect alendronic acid.

The elderly: alendronic acid can be used in the elderly.

Pregnancy and breastfeeding - please ensure you read the detailed information below

PREGNANCY
Alendronic acid is intended for use in postmenopausal women. Do not take it if you are, or think you
may be, pregnant.

It is sensible to limit use of medication during pregnancy whenever possible. However, your doctor
may decide that the benefits outweigh the risks in individual circumstances and after a careful
assessment of your specific health situation.

If you have any doubts or concerns you are advised to discuss the medicine with your doctor or
pharmacist.

BREAST FEEDING

It is not known if alendronic acid passes into breast milk. Given that alendronic acid is intended for
use in post-menopausal women, it should not be used in breastfeeding women.

It is sensible to limit use of medication during breastfeeding whenever possible. However, your doctor
may decide that the benefits outweigh the risks in individual circumstances and after a careful
assessment of your specific health situation.

If you have any doubts or concerns you are advised to discuss the medicine with your doctor or
pharmacist.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be
monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking
with them first.

This drug should not be taken with food or drinks (including mineral water), calcium supplements,
antacids, oral iron and some oral medicinal products, as they interfere with the absorption of
alendronic acid.

Before using this medication, tell your doctor or pharmacist of all prescription and non-
prescription/herbal products you may use.

This information does not contain all possible interactions. Therefore, before using alendronic acid,
tell your doctor or pharmacist of all the products you use.

OVERDOSE

If you take too many tablets by mistake, drink a full glass of milk and contact your doctor immediately.
Do not make yourself vomit, and do not lie down.

If you think you, or someone you care for, might have accidentally taken more than the recommended
dose of alendronic acid or intentional overdose is suspected, contact your local hospital, GP or if in
England call 111. In Scotland call NHS 24. In Wales, call NHS Direct Wales. In the case of medical
emergencies, always dial 999.

MISSED DOSE
 For the daily dose: If you miss a dose, skip the missed dose and resume your usual dosing schedule.
Do not double the dose to catch up.

For the weekly dose: If you miss a dose, just take one tablet on the morning after you remember. Do
not take two tablets on the same day. Return to taking one tablet once a week, as originally
scheduled on your chosen day.

Anxiety disorders

Anxiety disorders include panic disorder, phobias and post-traumatic stress disorder, or PTSD.

It is normal to feel anxious from time to time, but a person with ananxiety disorder has problems
controlling their worries to such an extent that they interfere with everyday life.

Anxiety disorders affect around 1 in 20 people in the UK.

What are the types of anxiety disorders?

There are several recognised types of anxiety disorders, including:

Panic disorder: People with this condition have feelings of terror that strike suddenly and
repeatedly with no warning. Other symptoms of a panic attackinclude sweating, chest pain,
palpitations (irregular heartbeats), and a feeling of choking, which may make the person feel like he
or she is having a heart attack.

Obsessive-compulsive disorder (OCD): People with OCD are plagued by constant thoughts
or fears that cause them to perform certain rituals or routines. The disturbing thoughts are called
obsessions, and the rituals are called compulsions. An example is a person with an unreasonable
fear of germs who constantly washes his or her hands.

Post-traumatic stress disorder (PTSD): PTSD is a condition that can develop following a
traumatic and/or terrifying event, such as a sexual or physical assault, the unexpected death of a
loved one, or a natural disaster. People with PTSD often have lasting and frightening thoughts and
memories of the event, and tend to be emotionally numb.

Social anxiety disorder: Also called social phobia, social anxiety disorder involves
overwhelming worry and self-consciousness about everyday social situations. The worry often
centres on a fear of being judged by others, or behaving in a way that might cause embarrassment or
lead to ridicule.

Specific phobias: A specific phobia is an intense fear of a specific object or situation, such as
snakes, heights, or flying. The level of fear usually is inappropriate to the situation and may cause the
person to avoid common, everyday situations.
 Generalised anxiety disorder: This disorder involves excessive, unrealistic worry and
tension, even if there is little or nothing to provoke the anxiety.

What are the symptoms of an anxiety disorder?

Symptoms vary depending on the type of anxiety disorder, but general symptoms include:

Feelings of panic, fear and uneasiness

Uncontrollable, obsessive thoughts

Repeated thoughts or flashbacks of traumatic experiences

Nightmares

Ritualistic behaviours, such as repeated hand washing

Problems sleeping

Cold or sweaty hands and/or feet

Shortness of breath

Palpitations

An inability to be still and calm

Dry mouth

Numbness or tingling in the hands or feet

Nausea

Muscle tension

Dizziness

What causes anxiety disorders?

The exact cause of anxiety disorders is unknown; but anxiety disorders -- like other forms of mental
health disorders -- are not the result of personal weakness or a character flaw. As scientists continue
their research into mental health problems, it is becoming clear that many of these disorders are
caused by a combination of factors, including changes in the brain and environmental stress.

Like certain illnesses, such as diabetes, anxiety disorders may be caused by chemical imbalances in
the body. Studies have shown that severe or long-lasting stress can change the balance of chemicals
in the brain that control mood. Other studies have shown that people with certain anxiety disorders
have changes in certain brain structures that control memory or mood. In addition, studies have
shown that anxiety disorders run in families, which means that they can be inherited from one or both
parents, like hair or eye colour. Certain environmental factors -- such as a trauma or significant event
 -- may trigger an anxiety disorder in people who have an inherited susceptibility to developing the
disorder.

How are anxiety disorders diagnosed?

If symptoms of an anxiety disorder are present, your GP will begin an evaluation by asking you
questions about your medical history and performing a physical examination. Although there are no
laboratory tests to specifically diagnose anxiety disorders, your GP may use various tests to look for
physical illness as the cause of the symptoms.

If no physical illness is found, you may be referred to a psychiatrist or psychologist, healthcare

professionals who are specially trained to diagnose and treat mental health disorders. Psychiatrists
and psychologists use specially designed interview and assessment tools to evaluate a person for an
anxiety disorder.

The diagnosis is based on the patient's report of the intensity and duration of symptoms, including
any problems with daily functioning caused by the symptoms -- and observation of the patient's
attitude and behaviour. This helps determine if the patient's symptoms and degree of dysfunction
indicate a specific anxiety disorder.

How are anxiety disorders treated?

Fortunately, much progress has been made in the last two decades in the treatment of people with
mental health disorders, including anxiety disorders. Although the exact treatment approach depends
on the type of disorder, one or a combination of the following therapies may be used for most anxiety
disorders:

Medication: Medicines used to reduce the symptoms of anxiety disorders include anti-
depressants and anxiety-reducing drugs.

Psychotherapy: Psychotherapy (a type of counselling) addresses the emotional response to

mental health disorders. It is a process in which trained mental health professionals help people by
talking through strategies for understanding and dealing with their disorder.

Cognitive-behavioural therapy (CBT): People suffering from anxiety disorders often

participate in this type of psychotherapy in which the person learns to recognise and change thought
patterns and behaviours that lead to troublesome feelings.

Dietary and lifestyle changes

Relaxation therapy

Can anxiety disorders be prevented?

Anxiety disorders cannot be prevented; however, there are some things you can do to control or
lessen symptoms:

Stop or reduce your consumption of products that contain caffeine, such as coffee, tea, cola
and chocolate if you find these make your symptoms worse.
 Ask your GP or pharmacist before taking any over-the-counter medicines or herbal remedies.
Many contain chemicals that can increase anxiety symptoms.

Seek counselling and support after a traumatic or disturbing experience.

Symptoms & types

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Are anxiety and fear interfering with your everyday life? Have you had a panic attack? These articles
will help you sort out the symptoms, in yourself or your child.

Symptoms
Anxiety attack symptoms: when worry takes control

Is anxiety affecting your work or personal life? Read on to learn more.

Panic attack symptoms

Types
What is panic disorder?

Learn the difference between normal anxiety and panic attacks.

Generalised anxiety disorder

Daily life becomes a constant state of worry, fear, and dread. Learn about the excessive worry that
accompanies generalised anxiety. Does it sound familiar?

Obsessive-compulsive disorder

Endless cycles of repetitive thoughts and behaviours, thats the pattern of OCD.

Understanding social anxiety

Social anxiety disorder is often called social phobia, an excessive fear of social situations. Learn
more about this common problem.

The fear factor: Phobias

Phobia is a persistent, excessive fear of a specific situation or object. Learn more about these very
common fears.

Posttraumatic stress disorder (PTSD)

This is a serious condition that develops after a traumatic event. This article will give you a better
understanding of PTSD.

Stage fright (performance anxiety)

 Millions of people suffer from performance anxiety, commonly called stage fright.

Complications
Dependent personality disorder

Emotional dependency puts people at risk for anxiety disorders and other mental health problems.
This article explains more.

Self-injury

People who suffer from obsessive-compulsive disorder, substance abuse, or an eating disorder are
also at risk for self-injury or self-harm. Read on to learn more.

Trichotillomania

Hair pulling is a type of impulse-control disorder, and is often linked with depression or anxiety. This
overview explains more.

Panic disorder

A person with panic disorder experiences recurring, regular panic attacks.

Having panic disorder is far more extreme than the everyday concerns and worries in life.

Panic attacks cause symptoms including fear, apprehension and anxiety, and physical symptoms,
including nausea, sweating, trembling and palpitations.

Around 1 in 100 people in the UK has panic disorder with the condition often developing after the age
of 20. Panic disorder affects around twice as many women as it does men.

What are the symptoms of panic disorder?

Symptoms of a panic attack, which often last about 10 minutes, include:

Difficulty breathing.

Pounding heart or chest pain.

Intense feeling of terror.

Sensation of choking or smothering.

Dizziness or feeling faint.

Trembling or shaking.

Sweating

Nausea or stomachache.

Tingling or numbness in the fingers and toes.

 Chills or hot flushes.

A fear that you are losing control or are about to die.

Beyond the panic attacks themselves, a key symptom of panic disorder is the persistent fear of
having future panic attacks. The fear of these attacks can cause the person to avoid places and
situations where an attack has occurred or where they believe an attack may occur.

What causes panic disorder?

Although the exact cause of panic disorder is not fully understood, studies have shown that a
combination of factors, including biological and environmental, may be involved. These factors
include.

Family history. Panic disorder has been shown to run in families. It may be passed on to
some people by one or both parent(s) much like hair or eye colour can.

Abnormalities in the brain. Panic disorder may be caused by problems in parts of the brain.

Substance abuse. Abuse of drugs and alcohol can contribute to panic disorder.

Major life stress. Stressful events and major life transitions, such as the death of a loved one,
can trigger a panic disorder.

How is panic disorder diagnosed?

If symptoms of panic disorder are present, the GP will begin an evaluation by looking at a persons
medical history and performing a physical examination. Although there are no laboratory tests to
specifically diagnose panic disorder, the doctor may use various tests to look for physical illness as
the cause of the symptoms.

If no physical illness is found, you may be referred to a psychiatrist or psychologist, doctors who are
specially trained to diagnose and treat mental illnesses. Psychiatrists and psychologists use specially
designed interview and assessment tools to evaluate a person for panic disorder.

The doctor bases his or her diagnosis on reported intensity and duration of symptoms, including the
frequency of panic attacks, and the doctor's observation of the patient's attitude and behaviour. The
doctor then determines if the symptoms and degree of dysfunction suggest panic disorder.

Dependent personality disorder

Dependent personality disorder (DPD) is one of a group of conditions called anxious personality
disorder. Read about the symptoms, causes, and treatment of dependent personality disorder.

What are the symptoms of DPD?

People with DPD become emotionally dependent on other people and make great efforts to try to
please others. People with DPD tend to display needy, passive, and clinging behaviour, and have a
fear of separation. Other common characteristics of this personality disorder include the following:

Inability to make decisions, even everyday decisions, without the advice and reassurance of
others
 Avoidance of personal responsibility; avoidance of jobs that require independent functioning
and positions of responsibility

Intense fear of abandonment and a sense of devastation or helplessness

whenrelationships end; A person with DPD often moves right into another relationship when one ends

Over-sensitivity to criticism

Pessimism and lack of self-confidence, including a belief that they are unable to care for
themselves

Avoidance of disagreeing with others for fear of losing support or approval

Inability to start projects

Difficulty being alone

Willingness to tolerate mistreatment and abuse from others

Placing the needs of their carers before their own

Tendency to be nave and live in a world of fantasy

What causes DPD?

Although the exact cause of DPD is not known, it is most likely to involve both biological and
developmental factors. Some researchers believe an authoritarian or overprotective parenting style
can lead to the development of dependent personality traits in people who are susceptible to the
disorder.

How Is DPD diagnosed?

If symptoms of DPD are present, the doctor will begin an evaluation by performing a complete
medical history and physical examination. Although there are no laboratory tests specifically to
diagnose personality disorders, the doctor can use various diagnostic tests to eliminate physical
illness as the cause of the symptoms.

If the doctor finds no physical reason for the symptoms, he or she may refer the person to a
psychiatrist or psychologist, health care professionals who are specially trained to diagnose and treat
mental illnesses. Psychiatrists and psychologists use specially designed interview and assessment
tools to assess a person for a personality disorder.

How Is DPD treated?

As with many personality disorders, people with DPD generally do not seek treatment for the disorder
itself. Instead, they might seek treatment when a problem in their lives -- often resulting from thinking
or behaviour related to the disorder -- becomes overwhelming, and they are no longer able to cope.
People with DPD are prone to developing depression or anxiety, and symptoms of these disorders
could prompt the individual to seek help.

Psychotherapy (a type of counselling) is the main method of treatment for DPD. The goal of therapy
is to help the person with DPD become more active and independent, and to learn to form healthy
relationships. Short-term therapy with specific goals is preferable because long-term therapy can lead
 to dependence on the therapist. Specific strategies could include assertiveness training to help the
person with DPD develop self-confidence.

Medication could be used to treat people with DPD who also suffer from depression or anxiety.
However, medication therapy must be carefully monitored because the person might become
dependent on or abuse the drugs.

Psychotherapy

Psychotherapy is a type of talking therapy used to help treat manymental health conditions and
emotional problems.

The therapy often involves talking to a specially trainedpsychotherapist one-to-one, with a partner or
in a group.

What's discussed in the sessions is confidential and aims to explore problems and concerns.

Some forms of psychotherapy use art, music, drama or movement as part of the therapy.

Psychotherapy often involves a programme of regular sessions with the therapist.

Access to NHS psychotherapy services can be through a referral from a GP or arranged privately.

How does psychotherapy help?

Psychotherapy helps people with a mental health disorder:

Understand the behaviours, emotions, and ideas that contribute to his or her problem.

Understand and identify the life problems or events -- like a major illness, a death in the family,
a loss of a job or a divorce, that contribute to their problem and help them understand which aspects
of those problems they may be able to solve or improve.

Regain a sense of control and pleasure in life.

Learn coping techniques and problem-solving skills.

Types of therapy

Therapy can be given in a variety of formats, including:

Individual: This therapy involves only the patient and the therapist.

Group: Two or more patients may participate in therapy at the same time. Patients are able to
share experiences and learn that others feel the same way, and have had the same experiences.

Marital/couples: This type of therapy helps spouses and partners understand why their loved
one has a mental disorder, what changes in communication and behaviours can help, and what they
can do to cope.

Family: Because the family is a key part of the team that helps people with mental health
problems get better, it is sometimes helpful for family members to understand what their loved one is
going through, how they themselves can cope, and what they can do to help.
Approaches to therapy

While therapy can be done in different formats -- like family, group, and individual -- there are also
several different approaches that mental health professionals can take to provide therapy. After
talking with the patient about their disorder, the therapist will decide which approach to use based on
the suspected underlying factors contributing to the condition.

Different approaches to therapy include:

Psychodynamic therapy

Psychodynamic therapy is based on the assumption that a person has a developed a mental health
problem because of unresolved, generally unconscious conflicts, often stemming from childhood. The
goal of this type of therapy is for the patient to understand and cope better with these feelings by
talking about the experiences. Psychodynamic therapy is administered over a period of three to four
months, although it can last longer, even years.

Interpersonal therapy

Interpersonal therapy focuses on the behaviours and interactions a patient has with family and
friends. The primary goal of this therapy is to improve communication skills and increase self-esteem
during a short period of time. It usually lasts three to four months and works well
for depression caused by mourning, relationship conflicts, major life events, and social isolation.