Aflac 100 mg. 10 tablets

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Aflac belongs to the group of non-steroidal anti-inflammatory and anti-rheumatic drugs.

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What Aflac is and what it is used for

Aflac belongs to the group of non-steroidal anti-inflammatory and anti-rheumatic drugs.

Aflac is used to treat conditions with acute inflammation and pain, such as lumbago (lower back pain), joint pain, toothache and dysmenorrhea. Aflac can be used to treat chronic joint diseases with chronic pain and inflammation, for example: chronic breakdown of joint cartilage (osteoarthritis), inflammation of a joint or joints of rheumatoid origin (rheumatoid arthritis) and arthritis that affects one or more from the intervertebral joints of the spine and leads to fusion and stiffness of the joints (ankylosing spondylitis) or other painful movement disorders, for example: "stiff shoulder" (humeroscapular periarthritis) and "tennis elbow".

2. What you need to know before you take Aflac

Do not take Aflac:

if you are allergic to aceclofenac or any of the other ingredients of this medicine (listed in section 6).

if you have had asthma, narrowing of the airways, acute rhinitis, skin rash or other allergic reaction after taking acetylsalicylic acid (eg aspirin) or another non-steroidal anti-inflammatory drug (eg ibuprofen, diclofenac or naproxen).

if you have or have had a stomach or duodenal ulcer, or bleeding from the gastrointestinal tract, active bleeding or other blood clotting disorders.

if you suffer from acute liver or kidney disease.

if you have established cardiovascular disease and/or cerebrovascular disease or have had:

heart attack, stroke or microstroke (transient ischemic attack);

blockage of the blood vessels of the heart or brain;

blood vessel unblocking or bypass surgery.

if you have or have had circulation problems (peripheral arterial disease)

in case of pregnancy (especially during the last 3 months).

Warnings in Precautions

Talk to your doctor or pharmacist before taking Aflac.

Pay special attention to them:

if you suffer from any form of kidney or liver disease;

if you have or have ever had a stomach or duodenal ulcer, or an inflammatory disease of the gastrointestinal tract (ulcerative colitis, Crohn's disease);

if you have ever had a cerebrovascular haemorrhage;

if you have asthma or other breathing problems;

if you suffer from the rare metabolic disease porphyria;

if you smoke;

if you have diabetes;

if you have chest pain, blood clots, high blood pressure, high cholesterol or high triglycerides;

if you suffer from an autoimmune disease called systemic lupus erythematosus;

if you have chicken pox, taking Aflac may lead to the development of a rare serious skin infection;

if you are recovering from major surgery;

if you suffer from blood clotting disorders.

Medicines such as Aflac may be associated with a slightly increased risk of a heart attack ("myocardial infarction").

The risk of side effects can be minimized by using the lowest effective dose for the shortest period of time.

Do not exceed the recommended dose and duration of treatment.

Serious skin reactions have been reported very rarely with medicines such as Aflac (see section 4). As with other nonsteroidal anti-inflammatory drugs, serious allergic reactions can occur even without prior use of the drug. The risk of such reactions is highest during the first month of treatment. Life-threatening dermatological conditions, some of which have been fatal (exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported very rarely after the use of anti-inflammatory drugs such as aceclofenac. Aflac should be stopped immediately at the first appearance of chest tightness, difficulty breathing, skin rash, itching, hives, skin blisters, fever, or other signs of hypersensitivity.

In rare cases, Aflac can cause gastrointestinal ulcers and bleeding or perforation. This can happen at any time during treatment with or without warning symptoms. If you notice any abdominal symptoms, especially if you are elderly, you should contact your doctor.

Aflac should not be used in case of chicken pox (chicken pox).

Children

The use of Aflac in children is not recommended due to a lack of data on safety and efficacy.

Other medicines and Aflac

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Some medicines can affect the effects of Aflac. In these cases, it may be necessary to change the dose or stop treatment with these drugs. This is especially important if you are taking:

medicines to treat depression such as selective serotonin reuptake inhibitors or for mental illness such as lithium;

drugs for the treatment of

steroidal anti-inflammatory drugs such as betamethasone and prednisolone;

tacrolimus and cyclosporine (medicines that suppress the immune system and are used to prevent rejection of transplanted organs);

mifepristone;

acetylsalicylic acid and other pain-relieving drugs (so-called nonsteroidal anti-inflammatory drugs), including COX-2 inhibitors;

blood sugar-lowering drugs (glibenclamide, gliclazide, tolbutamide);

antiplatelet agents (clopidogrel);

a drug to treat HIV

Aflac with food and drinks

Aflac film-coated tablets should preferably be taken with or after a meal.

Pregnancy, lactation and fertility

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

Aflac can make it harder to get pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems conceiving.

Do not take Aflac if you think you may be pregnant or have been pregnant (especially in the last 3 months).

It is not known whether Aflac is excreted in human milk, therefore it is not recommended to take Aflac while breastfeeding.

Driving and using machines

Do not drive or use dangerous tools or machinery if you feel dizzy, drowsy, lightheaded, or have any vision problems while taking Aflac.

3. How to take Aflac

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Aflac film-coated tablets should be swallowed whole, with a sufficient amount of liquid.

The recommended daily dose is 200 mg, equivalent to two Aflac tablets. One film-coated tablet should be taken in the morning and the second in the evening (one film-coated tablet every 12 hours).

Tablets should be taken whole, without breaking or chewing, with a sufficient amount of water during or after a meal.

Consult your doctor or pharmacist if you think that the effect of Aflac is too strong or too weak.

Old age

If you are elderly you are more likely to get any of the serious side effects (listed in section 4). If your doctor prescribes Aflac, it will be at the lowest effective dose and for the shortest period of time.

Kidney and heart diseases

The dose must be determined by your doctor, and periodic control examinations are necessary.

Liver diseases

The recommended dose should be reduced to one film-coated tablet daily.

Long-term treatment

If you continue to take Aflac, your doctor will perform follow-up laboratory tests every three months, such as blood counts and kidney tests.

If you take more Aflac than you should

Consult your doctor or pharmacist immediately, or go to the emergency department of the nearest hospital. Take this leaflet with you.

If you forget to take Aflac

If you miss a dose, don't worry, take your next dose at the usual time. Do not take a double dose to make up for a missed film-coated tablet.

If you stop taking Aflac

Do not stop the treatment in advance without the recommendation of your doctor.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the reactions listed below become serious or you get a side effect not described in this leaflet, please contact your doctor or pharmacist.

Common side effects (may affect up to 1 in 10 people): dizziness, nausea, diarrhea or increased liver enzymes in the blood.

Uncommon side effects (may affect up to 1 in 100 people): flatulence, gastritis (inflammation of the lining of the stomach), constipation, vomiting, inflammation of the lining of the mouth (mouth ulcers), itching, rash, skin inflammation , hives and an increase in blood urea and creatinine levels.

Rare side effects (may affect up to 1 in 1,000 people): gastrointestinal ulcer and bleeding, visual disturbances, high blood pressure, heart failure, dyspnoea (difficulty breathing or shortness of breath), hypersensitivity reactions, including severe allergic reactions called anaphylactic shock.

Very rare side effects (may affect up to 1 in 10,000 people): depression, sleep disorders (insomnia), unusual dreams, tremors (rhythmic, involuntary movements), drowsiness, headache, impaired or disturbed taste, numbness, tingling or skin soreness, dizziness, hearing ringing or other sounds without an external cause, heart attack or palpitations, hot flushes, difficulty breathing, inflammation of the lining of the mouth, intestinal perforation, exacerbation of gastrointestinal inflammation

5. How to store Aflac

Keep out of the reach of children.

To be stored below 30°C.

Do not use Aflak after the expiry date stated on the package. The expiration date corresponds to the last day of the specified month.

Medicines should not be disposed of down the drain or in the household waste container. Ask your pharmacist how to dispose of your unwanted medicines. These measures will help protect the environment.

6. Contents of the package and additional information

What Aflac contains

The active substance is 100 mg aceclofenac in each film-coated tablet.

The other ingredients are microcrystalline cellulose 101, microcrystalline cellulose 102, povidone K-25, croscarmellose sodium, glyceryl distearate.

Film coating: microcrystalline cellulose, hydroxypropyl methyl cellulose, macrogol 40 OE, stearate type 1, titanium dioxide.

What Aflac looks like and contents of the pack

Appearance: White, round, biconvex, film-coated tablets, packed in blisters. A cardboard box containing 10 or 20 tablets (one or two blisters of 10 tablets) and a leaflet. Not all packages can be put on sale.

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