MARKETING AUTHORIZATION no.

8676/2016/01-02 Appendix 1
Leaflet
Official stamp: Ministry of Health
National Agency of Medicines and Medical Devices
Chairman

LEAFLET: USERS INFORMATION

Diclofenac Helcor 50 mg, gastro-resistant tablets
Diclofenac sodium

Read carefully and entirely this leaflet before using this drug, because it contains
important information for you
- Keep this leaflet. You might need to read it once again.
- If you have any other further questions, contact your doctor or pharmacist.
- This drug was prescribed only for you. You should not give it to other persons. It
might harm them, even if they manifest the same symptoms as you do.
- If you notice any side effects, contact your doctor or pharmacist. This includes any
possible side effects not specified in the present leaflet. See section 4.

In this leaflet you find:

1. What Diclofenac Helcor is and what it is used for
2. Before you take Diclofenac Helcor
3. How to take Diclofenac Helcor
4. Possible side effects
5. How to store Diclofenac Helcor
6. Package content and additional information

1. What is Diclofenac Helcor and what it is used for

Diclofenac Helcor is a medicine that belongs to a nonsteroidal anti-inflammatory and
antirheumatic group of drugs (NSAID), derivatives of acetic acid and other related
substances.
Diclofenac Helcor ameliorates the pain and the inflammation; it is used to treat:
- rheumatic diseases: osteoarthritis, rheumatoid arthritis and ankylosing spondylitis
(back pain).
- mild to moderate pains that might occur during some small surgical procedures;
- muscle and joint aches, bone pains, due to effort or traumatisms;
- abdominal pains that might occur during menstruation.

2. Before using Diclofenac Helcor

Do not use Diclofenac Helcor if:
- you are allergic (hypersensitive) to the active ingredient or any other of the ingredients
of this medicinal product (listed in section 6);
- you are allergic (hypersensitive) to other NSAIDs or acetylsalicylic acid (e.g. you had
a crisis of bronchial asthma, rash or acute rhinitis after having taken these drugs );
- you suffer of gastro-duodenal ulcer or other intestinal inflammatory bowel diseases;
- your stomach or bowels bleeds;
- you are during the last 4 months of pregnancy;
- you breastfeed;
- you suffer of serious liver or renal failure;
- to children under the age of 15;

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 - if you have established heart disease and/or cerebrovascular disease e.g. if you have
had a heart attack, mini-stroke (TIA) or blockages to blood vessels to the heart or
brain or an operation to clear or bypass blockages;
- if you have or have had problems with your blood circulation (peripheral arterial
disease).

Warnings and precautions

Before use Diclofenac Helcor, ask your doctor or pharmacist.
- if you suffer from bronchial asthma;
- if you are allergic to other medicines or food additives (e.g. preservative agents);
- if you suffer from diseases that cause you fluid or salt retention in your body,
congestive heart failure, edema;
- if you suffer from high blood pressure;
- if you suffer from infections;
- if you suffer from renal and liver failure.

Make sure your doctor knows these before you are given diclofenac:
- if you are smoking
- if you have diabetes
- if you have angina, blood clots, high blood pressure, raised cholesterol or raised
triglycerides.

Side effects may be minimized by using the lowest effective dose for the shortest duration
necessary for controlling the symptoms.

It is necessary to estimate the therapeutic risk/benefit ratio in the event of liver and renal
failure (risk of increased toxicity from drug accumulation).
Caution is required in surgical interventions because of the increased risk of bleeding.

Medicines as Diclofenac Helcor can be associated with a slightly high risk of myocardial
infarction or stroke occurrence. Risks of any kind are more likely to occur when administered
at high doses and in long-term treatment. Do not exceed the dosage and the term prescribed
for the specific treatment.

If you suffer from heart diseases or have a stroke in your history, or consider you might put
yourself in a risky situation due to the above mentioned diseases (e.g. if you suffer from high
blood pressure, diabetes mellitus, high values of cholesterol or if you are a smoker), you
should discuss about your treatment with your doctor or with your pharmacist.

Elderly
Careful monitoring of patients is required in this age group. Lower doses than usual should be
used since the elimination of diclofenac is low in impaired liver function or renal failure. The
risk of gastrointestinal toxicities is high.

Use of Diclofenac Helcor with other drugs

You should let you doctor or pharmacist know if you are taking or have recently taken any
other kinds of medicines.
Careful monitoring is required when the administration of diclofenac is associated with the
following drugs:
- other nonsteroidal anti-inflammatory drugs risk of ulcerations and digestive
bleeding;

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 - acetylsalicylic acid it decreases the plasma concentration of diclofenac;
- glucocorticoids risk of ulcerations and digestive bleeding;
- coumarin oral anticoagulants risk of bleeding (prothrombin time should be
monitored and dosage adjusted);
- heparins risk of bleeding;
- ticlopidine and other platelet aggregation inhibitors (it causes an increase of the risk of
bleeding);
- thrombolytic agents: alteplase, streptokinase (risk of bleeding);
- lithium it increases its plasma concentration (risk of toxicity);
- methotrexate it increases the hematologic toxicity;
- diuretics diclofenac can reduce the natriuretic effect of furosemide and thiazides,
risk of hyperpotassemia in combination with antialdosteronic diuretics; renal failure
may occur, requiring close monitoring of patients;
- angiotensin-converting enzyme inhibitors: diclofenac can diminish their
antihypertensive effect;
- antihypertensive drugs disposition to water and salt retention in body (the treatment
monitoring is necessary);
- beta-blockers: they decrease the antihypertensive effect;
- digoxin it increases its plasma concentration in blood and the toxic risk; (the
treatment has to be monitored);
- cyclosporine, gold compounds, nephrotoxic medication it increases the plasma
concentration and the nephrotoxic effects;
- zidovudine a high risk of hematologic toxicity;
- photosensitizing medication additive photosensitizing effects appear.
Your doctor will inform you about the medicines that require special attention in the event of
combined administration with Diclofenac Helcor or the drugs that must be avoided.

Changes caused to laboratory test results

Diclofenac can cause slight changes in the serum transaminase levels (if they remain the same
or complications occur, the treatment should be discontinued) and kaliemia may increase.

Use of Diclofenac Helcor with food, beverages and alcohol

No interaction with food or beverages has been detected.

Pregnancy, breastfeeding and fertility

If you are pregnant or breast-feeding, you think you may be pregnant or planning to become
pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine during pregnancy.
Do not use Diclofenac Helcor if you are in the last 4 months of pregnancy.
Diclofenac has a toxic effect on the heart and lungs (premature closure of the arterial duct)
and kidneys of the unborn child.
It extends labor.

Breastfeeding
Do not use Diclofenac Helcor if you breastfeed (it is excreted in small amounts into breast
milk). If its administration in more consecutive doses is absolutely necessary, breast-feeding
must be avoided.

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Driving vehicles and using machineries
The use of Diclofenac Helcor requires caution, because the effects on the central nervous
system may alter the ability to drive or operate machinery.

Diclofenac Helcor contains lactose monohydrate

If your doctor has specifically pointed out that you manifest intolerance to some categories of
carbohydrates, we advise you to ask for his opinion before taking this medicine.

3. How to use Diclofenac Helcor

You should always use Diclofenac Helcor exactly as your doctor prescribed it. You should
check with your doctor or pharmacist if you are unsure.
Adults and adolescents over 15 years old
Long-term treatment: the initial dose is 3 gastro-resistant tablets of Diclofenac Helcor 50 mg
(150 mg diclofenac sodium) per day, administered in 2-3 doses; as maintenance therapy there
are administered 1-2 gastro-resistant tablets of Diclofenac Helcor 50 mg (50-100 mg
diclofenac sodium) per day.
- short-term treatment: oral administration of 3 gastro-resistant tablets of Diclofenac
Helcor 50 mg per day, divided in 2-3 doses.
Diclofenac Helcor is not recommended for children under 15 years old.
Side effects can be minimized by using the lowest effective dose for the shortest duration
necessary to control the symptoms.
If you feel that the effect produced by Diclofenac Helcor is too strong or too weak, you
should check with your doctor or pharmacist.

If you take more tablets of Diclofenac Helcor than you should

If you take more tablets of Diclofenac Helcor than you should have, contact your doctor or go
to the nearest hospital. Keep the leaflet and all the remaining tablets so that you can show
them to the doctor.

If you forget to take Diclofenac Helcor

If you miss a dose, take another one as soon as you remember. Still, if its time to take the
next dose, take only that one. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Diclofenac Helcor

If you have any further questions concerning this product, contact your doctor or pharmacist.

4. Possible side effects

As all drugs, Diclofenac Helcor can cause side effects, although not everybody gets them.
The side effects are classified depending on their frequency, using the following convention:
- Very common side effects (they occur in more than 1 out of 10 persons);
- Common side effects (they occur in less than 1 out of 10 persons);
- Uncommon side effects (they occur in less than 1 out of 100 persons);
- Rare side effects (they occur in less than 1 out of 1000 persons);
- Very rare side effects (they occur in less than 1 out of 10000 persons);
- Side effects with unknown frequency (it cannot be estimated based on the available
data);

Very common side effects:

- Gastrointestinal disorders: abdominal pains, changes of the intestinal transit, bloating,
bleedings/perforations, nausea, vomiting, gastro-duodenal ulcer;

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 - Other reactions: affecting the renal function, dizziness, edema, cephalalgia, transitory
rash, tinnitus, anemia, increase of the liver enzymes, increased bleeding time.

Uncommon side effects:

- General disorders: fever, infection;
- Cardiac disorders: tachycardia, loss of consciousness;
- Gastrointestinal disorders: dry mouth, inflammation of mouth and esophagus,
gastritis, glossitis, blood vomiting, dark stool or with fresh blood in stool, hepatitis,
icterus;
- Hematologic and lymphatic disorders: eosinophilia, leucopenia, thrombocytopenia;
- Metabolic and nutritional disorders: body weight changes;
- Nervous system disorders: sensation of fear, asthenia, confusion, depression, abnormal
dreams, lethargy, insomnia, malaise, irritability, paresthesia, drowsiness, tremors,
vertigo;
- Respiratory disorders: asthma crises, difficult breathing;
- Skin and subcutaneous tissue disorders: alopecia, photosensitivity, heavy sweating;
- Visual disorders: blurred vision.
- Reproductive system and breast disorders: cystitis, dysuria, hematuria, interstitial
nephritis, oliguria/polyuria, proteinuria, renal failure.
Rare side effects:
- Immune system disorders: rash, angiodema, toxic epidermal necrolysis, erythema
multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, Quinckes edema,
anaphylactic shock;
- Cardiac disorders: disorders of the heart rhythm, arterial hypotension, myocardial
infarction, palpitations, vasculitis;
- Gastrointestinal disorders: colitis, hepatic failure, pancreatitis, appetite changes;
- Hematologic and lymphatic disorders: agranulocytosis, hemolytic anemia, aplastic
anemia, lymphadenopathy, pancytopenia;
- Metabolic and nutritional disorders: hyperglycemia.
- Nervous system disorders: convulsions, coma, hallucinations, meningitis;
- Respiratory disorders: respiratory depression, pneumonia;
- Eye disorders: conjunctivitis;
- Acoustical and vestibular disorders: decrease of hearing.
If you face one of the following side effects, make sure you immediately contact your doctor
or go to the nearest hospital:
- symptoms of stomach problems: abdominal pains, vomiting with blood, coffee ground
vomiting, dark stools, stools with blood, diarrhea with blood;
- symptoms of liver troubles: weariness, pains in the right side of the abdomen,
yellowish skin or/and eyes, discolored urine;
- appetite changes;
- skin: skin reddening, appearance of blebs, skin exfoliation, bleeding of lips, eyes, nose
or reproductive organs; these symptoms can be accompanied by fever and shivers;
- change in the urine color or quantity, increased frequency of urination, blood in urine,
pains with urination.
- chest pains.
These side effects are very serious and you should immediately contact your doctor or go to
the nearest hospital. The most severe side effects are rare.
Drugs such as Diclofenac Helcor can be associated with a slightly increased risk of cardiac
arrest myocardial infarction or stroke occurrence.
If any side effect gets serious, or if you notice any side effect not listed in this leaflet, please
tell your doctor or pharmacist.

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Reporting of adverse reactions
If any side effects occur, ask your doctor or pharmacist. This includes any side effects not
listed in this leaflet. Also, you can report adverse reactions via the national reporting system,
the details of which are published on the website of the National Agency of Medicines and
Medical Devices http://www.anm.ro. Reporting side effects you can help provide more
information on the safety of this drug.

5. How to store Diclofenac Helcor

Keep out of reach and sight of children.

Do not take Diclofenac Helcor after the expiry date written on its package, after EXP. The
expiry date refers to the last day of that month.

Store at a temperature below 25C, in the original package.

Medicines should not be disposed via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help protect the
environment.

6. PACKAGE CONTENT AND ADDITIONAL INFORMATION

Ingredients of Diclofenac Helcor
- The active substance is diclofenac sodium. Each tablet contains 50 mg diclofenac
sodium.
- The other ingredients are: core: corn starch, lactose monohydrate, microcrystalline
cellulose, povidone K 30, anhydrous colloidal silicon dioxide, croscarmellose sodium,
magnesium stearate, sodium lauryl sulfate; film coating: Acryl-Eze Green
(Methacrylic Acid Copolymer, type C; talc, titanium dioxide, triethyl citrate,
Quinoline Yellow (E104), yellow iron oxide (E 172), black iron oxide (E 172),
colloidal silicon dioxide, sodium hydrogen carbonate, indigotin (E 132), sodium
lauryl sulfate).

How Diclofenac Helcor looks like and contents of the pack

Diclofenac Helcor comes in lenticular, green tablets of 7 mm diameter.

It is available in boxes of 2 or 100 blisters of A1/PVC of 10 gastro-resistant tablets.

Marketing authorization holder

S.C. AC HELCOR PHARMA SRL
50 Victor Babe street, Baia-Mare, county of Maramure, Romania

Manufacturer
S.C. AC HELCOR SRL
62 Victor Babe street, Baia-Mare, county of Maramure, Romania

For any information about this medicine, please contact the local representative of the
marketing authorization holder.

This leaflet has been revised in August 2016.