50 mg film-coated tablet
diclofenac potassium
1. What Diclofenac T Apofri is and what it is used for
Diclofenac T Apofri belongs to the group of non-steroidal anti-inflammatory / anti-rheumatic drugs ( NSAIDs ). They relieve pain, reduce inflammation and lower fever.
Diclofenac T Apofri is used to treat mild to moderate pain conditions, e.g. headache including treatment of migraine , toothache, muscle and joint pain and back pain. Fever in colds. Menstrual cramps.
Diclofenac contained in Diclofenac T Apofri may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.
What you need to know before you use Diclofenac T Apofri
Do not use Diclofenac T Apofri
- if you think you are allergic to diclofenac , acetylsalicylic acid , ibuprofen or any other NSAID (non-steroidal anti-inflammatory drug), or any of the other ingredients of this medicine (listed in section 6). ). Signs of a hypersensitivity reaction include swelling of the face and mouth ( angioedema ), breathing problems, chest pain, runny nose, rash or other allergic reactions.
- if you have stomach ulcers or duodenal ulcers
- if you have had stomach ulcers or duodenal ulcers with previous treatment with diclofenac or similar preparations
- if you have had recurrent stomach ulcers or duodenal ulcers
- if you have an increased tendency for bleeding
- if you have porphyria (metabolic disease)
- if you have severe liver failure or kidney failure
- if you have previously had allergic reactions such as asthma , runny nose or rash while taking painkillers containing acetylsalicylic acid or other pain / inflammation medicines in the NSAID group (non-steroidal anti-inflammatory drugs).
- during the last 3 months of pregnancy (see section Pregnancy and breast-feeding ).
- if you have a known heart disease and / or disease of the blood vessels of the brain, e.g. heart attack, stroke , “mini-stroke” ( transient ischemic attack, TIA ). You may also have had narrowing of the blood vessels to the heart or brain, or have had surgery for such narrowing by clearing vessels one by one or via a bypass operation.
- if you have or have had problems with blood circulation ( peripheral vascular disease).
Warnings and cautions
Talk to your doctor before taking Diclofenac T Apofri.
Side effects can be minimized by treating with the lowest effective dose for the shortest possible time. In general, higher doses than recommended may increase the risk of side effects . This means that the combination of several NSAIDs at the same dose should be avoided.
Medicines such as Diclofenac T Apofri may cause a small increased risk of heart attack or stroke . Such an increase in risk is more likely with the use of high doses and with long-term treatment. Do not exceed the recommended dose or treatment time.
Consult your doctor before treatment, if you have or have had the following diseases:
- – stomach ulcer or duodenal ulcer or heartburn / discomfort in the stomach
- inflammatory bowel diseases (such as ulcerative colitis , Crohn’s disease )
- asthma , seasonal allergy , nasal polyps, chronic obstructive pulmonary disease (COPD) or chronic infection of the respiratory tract
- angina, blood clots, high blood pressure or heart failure
- liver or kidney disease
- SLE (connective tissue disease)
- diseases with an increased tendency to bleed
- diabetes
For chickenpox, this medicine should not be used.
Before you are given diclofenac , tell your doctor:
- if you smoke
- if you have high cholesterol or triglyceride levels (blood fats)
- if you have recently had surgery or are about to have surgery on your stomach or intestinal tract before taking Diclofenac T Apofri, as Diclofenac T Apofri can sometimes impair the healing of wounds in the intestines after surgery.
Elderly people should be aware of the increased risk of side effects that exist in old age.
Stomach bleeding can occur at any time during treatment with or without warning symptoms. This generally has more serious consequences in the elderly. Especially at the beginning of treatment, patients who have previously had problems with the gastrointestinal tract, especially elderly patients, should contact a doctor in case of symptoms from the abdomen.
Like other anti-inflammatory drugs, Diclofenac T Apofri may mask signs or symptoms of infection .
Diclofenac T Apofri can in rare cases affect the white blood cells so that the defense of infection deteriorates. If you get an infection with symptoms such as fever with severe general deterioration or fever with local infection symptoms such as sore throat / pharynx / mouth or urination problems, you should see a doctor as soon as possible so that a blood test can rule out a lack of white blood cells ( agranulocytosis ) . It is important that you then inform about your medication.
Like other anti-inflammatory drugs, Diclofenac T Apofri can rarely cause allergic reactions, including allergic shock. This can also happen when taking diclofenac for the first time.
Stop taking Diclofenac T Apofri and contact a doctor immediately if swelling of e.g. a. face, tongue and / or throat and / or difficulty swallowing or hives appearing together with difficulty breathing.
Severe skin reactions when using NSAIDs have been reported in very rare cases. Stop taking Diclofenac T Apofri and consult a doctor if you get a rash or damage to the mucous membranes.
The use of Diclofenac T Apofri (as well as all medicines that inhibit cyclooxygenase / prostaglandin synthesis ) may make it more difficult to get pregnant. Talk to your doctor if you are planning a pregnancy or if you have problems getting pregnant. The effect is temporary, ie ceases when you stop using these types of drugs.
The use of Diclofenac T Apofri may make it difficult for you to get pregnant. For more information, see the section Pregnancy and breast-feeding .
Other medicines and Diclofenac T Apofri
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Some medicines may be affected by treatment with Diclofenac T Apofri, eg:
- anticoagulants (eg warfarin , ticlopidine, acetylsalicylic acid, heparin )
- methotrexate (used against tumors and disorders of the immune system, such as rheumatism and psoriasis )
- medicines for the treatment of diabetes , with the exception of insulin
- lithium (used in manic depression)
- digoxin (used for heart problems)
- ciclosporin and tacrolimus (used in transplants, in severe psoriasis and rheumatism)
- certain medicines for high blood pressure (so-called beta-blockers and ACE inhibitors ), diuretics ( diuretics also used for high blood pressure )
- quinolone antibiotics (used in urinary tract infections)
- zidovudine (used to treat HIV )
- corticosteroids (used to treat inflammatory diseases)
- cholestipol or cholestyramine (used for high blood fats)
- fluconazole and voriconazole (used for fungal infections)
- rifampicin ( antibiotics for tuberculosis )
- carbamazepine and phenytoin (used in epilepsy )
- barbiturates (sleeping pills)
- diazepam (sedatives)
- pentoxifylline (vasodilators)
- selective reuptake inhibitors (antidepressants)
- sulfinpyrazone ( gout remedy ).
Never use several different painkillers at the same time without consulting a doctor or pharmacist.
Diclofenac T Apofri with food and drink
The tablets are swallowed whole along with liquid. For best effect, the tablets should not be taken with or immediately after a meal.
Pregnancy, breastfeeding and fertility
The use of Diclofenac T Apofri (as well as other NSAIDs ) may make it more difficult to conceive. Talk to your doctor if you are planning a pregnancy or if you have problems getting pregnant. The effect is temporary, ie ceases when you stop using these types of drugs.
Pregnancy
Pregnant women should not use Diclofenac T Apofri during the last three months of pregnancy. Taking Diclofenac T Apofri should be avoided by women who are trying to conceive or are pregnant. Treatment during any part of the pregnancy should only be done after a doctor’s prescription .
Breast-feeding
The drug passes into breast milk. Therefore, in order to avoid harmful effects on the baby, Diclofenac T Apofri should not be used during breast-feeding.
Driving and using machines
Diclofenac T Apofri can cause side effects such as visual disturbances, dizziness and drowsiness, which should be considered at times when sharper attention is required, such as when driving and when working that requires precision.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Diclofenac T Apofri contains lactose and benzoic acid (E210)
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Diclofenac T Apofri contains 0.0010 mg benzoic acid per film-coated tablet.
How to use Diclofenac T Apofri
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Dose one is determined by the doctor, who adjusts it individually for you. Dosage one and the duration of treatment are determined depending on the pain condition.
Migraine attacks
Usual dose for adults: 1 tablet is taken at the first sign of a migraine attack. If relief is not achieved within 2 hours, take another tablet. This can be repeated once more after 4-6 hours, but not more than 150 mg per day. Do not exceed the indicated dose one.
Other acute pain conditions, such as headaches, toothaches or menstrual pains and fever in colds
Usual dose for adults: 25-50 mg every 4 to 6 hours as needed. Do not take more than 150 mg per day, which is equivalent to 3 tablets per day. Do not exceed the indicated dose one. The tablet is not divisible. If a strength of 25 mg is desired, a lower strength must be used.
The tablets are swallowed whole along with liquid. For best effect, tablets should not be taken with a meal.
If you have the impression that the effect of Diklofenak T Apofri is too strong or too weak, talk to your doctor or pharmacist.
If you use more Diclofenac T Apofri than you should
If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital or the Poison Information Center (tel. 112) for risk assessment and advice.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
At the beginning of the treatment, gastrointestinal problems may occur. These side effects usually go away within a few days, see also section 2, Take special care with Diclofenac T Apofri .
Some side effects can be serious. Stop using Diclofenac T Apofri and tell your doctor straight away if you notice the following:
Mild cramping and tenderness in the stomach, which begins shortly after starting treatment with Diclofenac T Apofri and is followed by rectal bleeding or bloody diarrhea, usually within 24 hours of the onset of abdominal pain (reported, occurring in an unknown number of users). Chest pain, which may be a sign of a potentially serious allergic reaction called Kouni’s syndrome.
Other side effects that may occur:
Common (may affect more than 1 in 100 people): Stomach pain, nausea, vomiting, diarrhea, indigestion, decreased appetite, increased flatulence, headache, dizziness, dizziness, skin rash and elevated liver values.
Uncommon (may affect less than 1 in 100 people): Fatigue, bronchospasm.
Rare (may affect less than 1 in 1,000 people): Hypersensitivity reactions including allergic shock reaction with drop in blood pressure, hives , asthma , loss of sensation, impotence (connection uncertain), swelling in the body (due to fluid retention), inflammation of the stomach, stomach ulcers, stomach bleeding (blood-mixed vomiting, blood in the stool, bloody diarrhea), liver dysfunction (hepatitis, jaundice), drowsiness.
In rare cases, severe skin infections are associated with chickenpox.
Very Rare (may affect less than 1 in 10,000 people):
Anxiety, nightmares, insomnia, irritability, depression, memory loss, confusion, impaired perception of reality, tingling, tremors, convulsions, altered taste, eczema and other skin reactions (incl. Severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis ), angioedema (eg swelling of the face, rash, difficulty breathing), redness of the skin, hair loss, photosensitivity reactions of the skin, itching , intestinal problems (eg inflammation , constipation), worsening of ulcerative colitis or Crohn’s disease , inflammation of the tongue, mouth or esophagus, inflammationin the pancreas, blood image effect (reduced number of platelets that can cause small bleeding in the skin and mucous membranes, reduced number of white blood cells (including agranulocytosis ) that can impair the immune system, decay of red blood cells , anemia , effects on the heart and vessels (eg heart pain, high blood pressure , heart failure , myocardial infarction), inflammation of blood vessels, pneumonia Impact on the kidneys (may cause decreased or stopped urine production and blood in the urine) Impact on vision (blurred vision, double vision) and hearing (impaired hearing, tinnitus).
Medicines such as Diclofenac T Apofri may cause a small increased risk of heart attack or stroke .
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address
5. How to store Diclofenac T Apofri
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
Table of Contents
– The active substance is diclofenac potassium. One tablet contains
50 mg of diclofenac potassium.
The other ingredients are lactose monohydrate 54.4 mg, maize starch, microcrystalline cellulose, magnesium stearate, sodium starch glycolate, hypromellose, macrogol, talc, simethicone, sorbic acid, benzoic acid, macrogol stearate, mono- and diglycerides, titanium dioxide1 (nitric oxide) .
What the medicine looks like and contents of the pack
Diclofenac T Apofri are reddish-brown, round, biconvex tablets.
Pack sizes:
Carton with 10, 20, 30, 40, 50, 60, 80, 100 and 120 tablets in PVC / PVDC blister sealed with aluminum foil.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Evolan Pharma AB
Box 120
182 12 Danderyd
Sweden
Information is provided by
Apofri AB
Box 120
182 12 Danderyd
Phone: 08-544 960 30
Email: info@apofri.se
Manufacturer
Evolan Pharma AB
Box 120
182 12 Danderyd
Sweden
Medicofarma SA
Ul. Tarnobrzeska 13
Radom 26-613
Poland