25 mg film-coated tablets. diclofenac potassium

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if they show symptoms similar to yours.
  • If you get any side effects , talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about:
1. What Ignorin is and what it is used for
2. What you need to know before taking Ignorin
3. How to use Ignorin
4. Possible side effects
5. How to store Ignorin
6. Contents of the packaging and other information

1. What Ignorin is and what it is used for

Ignorin is a painkiller that relieves inflammation in muscles, joints, and connective tissue.

Ignorin is used to treat adults against:

  • Acute inflammatory conditions with pain in joints and muscles.
  • Menstrual cramps.
  • Acute migraine attacks with or without warning.

Ignorin 25 mg film-coated tablets are also used to treat children and adolescents from 9 years of age against:

  • Pain caused by ear, nose or throat infections. Your child’s doctor may also prescribe other medicines to treat the underlying infection . Ignorin should not be used to treat only fever but concomitant inflammation .
  • Severe or sudden pain after minor surgery.

Diclofenac contained in Ignorin may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before you take Ignorin

Do not take Ignorin

  • 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 are allergic to peanuts or soy.
  • 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 through a bypass operation
  • if you have or have had problems with blood circulation ( peripheral vascular disease)
  • if you have a history of stomach ulcers or ulcers in the duodenum a ( duodenal ulcer ), increased risk of bleeding / holes in the gut wall or previous bleeding in the stomach / intestinal tract after use of painkillers ( NSAIDs )
  • if you have asthma
  • if you have severe renal impairment
  • if you have severe hepatic impairment
  • if you are pregnant and have less than three months left until delivery
  • if you have an increased tendency to bleed
  • if you have porphyria .

Warnings and cautions

Side effects can be minimized by treating with the lowest effective dose for the shortest possible time. A higher dose than the recommended dose is generally associated with an increased risk of side effects.

Before you are given diclofenac, tell your doctor

  • if you have recently had or are going to have surgery on your stomach or gastrointestinal tract as diclofenac may make healing worse after surgery
  • if you smoke
  • if you have diabetes
  • if you have angina, blood clots, high blood pressure , high cholesterol or triglyceride levels (blood fats)
  • if you have stomach / intestinal problems or heartburn / stomach discomfort
  • if you have Crohn’s disease or ulcerative colitis
  • if you have asthma , liver disease or kidney disease
  • if you have diseases that increase the tendency to bleed
  • if you have SLE (connective tissue disease).

Tell your doctor immediately :

  • If you get stomach pain or if you get bleeding from the gastrointestinal tract when you are treated with Ignorin.
  • If you get a rash or other allergic reactions. Severe skin reactions have been reported in very rare cases in connection with the treatment of NSAIDs .

Elderly people should be aware of the increased risk of side effects that come with increasing age.

Prolonged use of painkillers (regardless of type) for headaches can cause aggravated headaches. If this is experienced or suspected, seek medical advice and discontinue treatment.

As with other anti-inflammatory drugs, Ignorin can mask the symptoms of infection.

For chickenpox, this medicine should not be used.

Medicines such as Ignorin may increase the risk of heart attack or stroke.

Such an increase in risk is more likely when using high doses and at

long-term treatment. Do not exceed the recommended dose or treatment time.

The use of Ignorin may reduce fertility and is therefore not recommended for women trying to conceive. Talk to your doctor if you are planning a pregnancy or if you have problems getting pregnant. The effect is reversible and ceases upon discontinuation of these types of drugs.

Always tell the appropriate person that you are being treated with Ignorin when taking blood or urine samples.

Other medicines and Ignorin

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines, medicines purchased abroad, herbal medicines, and strong vitamins and minerals.

Tell your doctor if you are using :

  • Diuretics ( diuretics ), including potassium-sparing diuretics .
  • Blood thinners (eg warfarin , clopidogrel and ticlopidine).
  • Lithium (medicine for depression).
  • Selective serotonin reuptake inhibitors, SSRIs (medicines for depression and various types of anxiety disorders).
  • Medicines for diabetes (tolbutamide, glibenclamide, glimepiride).
  • Medicines for high blood pressure ( ACE inhibitors and angiotensin II antagonists ).
  • Cholestyramine and cholestipol (medicines for high cholesterol ).
  • Ciclosporin and tacrolimus (medicines to suppress the immune system).
  • Cortisone preparations in tablet or injection form, eg prednisone (medicine for immune reactions and inflammation ).
  • Acetylsalicylic acid and other pain and swelling medications ( NSAIDs ).
  • Digoxin (heart medicine).
  • Rifampicin ( antibiotics for tuberculosis ).
  • Carbamazepine (used in epilepsy ).
  • St. John’s wort .
  • Methotrexate (for arthritis, severe skin diseases and cancer).
  • Medicines for infection (eg ciprofloxacin and levofloxacin).
  • Phenytoin , a drug used to treat epilepsy .
  • Amiodarone (used for arrhythmias in the heart).
  • Trimethoprim (used to prevent or treat urinary tract infection).
  • Voriconazole or fluconazole used for fungal infections and sulfinpyrazone used for gout (strong CYP2C9 inhibitor).
    Doctors may need to adjust dose one.
    NSAIDs (eg ibuprofen , acetylsalicylic acid ) may reduce the effect of diuretics ( diuretics ) and other types of antihypertensive drugs such as ACE inhibitors and angiotensin II antagonists . In some patients with renal impairment (patients who are dehydrated and elderly patients), concomitant treatment with ACE inhibitors and angiotensin II antagonists or other NSAIDs may befurther impair renal function. This effect is often transient. The combination should be used with caution, especially for the elderly. The patient should be given a sufficient amount of fluid and the kidney function should be checked after starting combination therapy and regularly thereafter.

Ignorance with food, drink and alcohol

You can take Ignorin with food and drink.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Ignorin must not be used during the last three months of pregnancy. Ignorance should be avoided by women who are trying to conceive or who are pregnant. Treatment with Ignorin, regardless of the phase of pregnancy, should only be done as prescribed by a doctor.

Ignorin should not be used during breastfeeding as it is excreted in small amounts of breast milk and may cause side effects in the baby.

Ignorance can make it harder to get pregnant. Talk to your doctor if you are planning to become pregnant or if you have problems getting pregnant.

Driving and using machines

Some patients taking Ignorin may experience side effects that may affect their ability to drive and use machines, such as visual disturbances, dizziness, dizziness, and drowsiness. If you experience any of these side effects, do not drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. 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.

Ignorin contains soybean oil

Ignorin contains soybean oil. Do not use Ignorin if you are allergic to peanuts or soy.

This medicine contains less than 1 mmol sodium (23 mmol) per tablet and is essentially ‘sodium-free.

3. How to use Ignorin

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is:

Adults

Acute inflammatory conditions in muscles and joints

50-150 mg daily in 2-3 divided doses.

Migraine

50 mg at the first sign of a migraine. If the pain does not subside after two hours, an additional 50 mg can be taken.

The maximum daily dose is 150 mg.

Elderly patients

Dose one may need to be lowered. Follow your doctor’s instructions.

Children

Ignorin 25 mg film-coated tablets can be given to children and adolescents from 9 years of age for treatment of the conditions described in section 1 above, but only according to the doctor’s prescription. Doctors will determine an appropriate dose for your child, based on body weight. The usual dose is 2 mg per kg body weight per day. This dose is normally divided into three to four separate dose occasions.

Impaired kidney and liver function

Dose one may need to be lowered. Follow your doctor’s instructions.

The tablets should be swallowed whole with water, preferably before a meal.

If you use more Ignorin than you should 

If you have ingested too much medicine or if e.g. a child ingested the medicine accidentally contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

Symptoms of overdose:

  • Nausea and vomiting.
  • Dizziness.
  • Wandering and clumsy movements that develop into unconsciousness and cramps.
  • Effects on renal and hepatic function.
  • Low blood pressure .
  • Breathing difficulties.
  • Effects on blood ability to coagulate (clotting ability).

If you forget to use Ignorin

If you forget to take Ignorin, take the next dose as planned. Do not take a double dose to make up for a forgotten dose

If you stop using Ignorin

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

4. Possible side effects

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

Some side effects can be serious. Stop using Ignorin and tell your doctor straight away if you notice any of the following:

  • Mild abdominal cramps and soreness, which begin shortly after starting Ignorin treatment and are 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).

Gastric ulcer can occur at any time during treatment with or without warning. The consequences are usually more severe in elderly patients. If this occurs or if other unexpected symptoms occur, consult a physician. Ignorin can cause a decrease in white blood cells and thus reduce your resistance to infection . If you get an infection with symptoms such as fever and severe general malaise, or fever with local symptoms such as sore throat / throat / mouth or urinary tract problems, contact a doctor immediately. A blood sample will be taken to check the number of white blood cells and if there is a decrease in the number ( agranulocytosis). It is important to inform your doctor about your medicine.

Medications such as Ignorin may increase the risk of heart attack and 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.

The most common side effects with Ignorin are gastrointestinal discomfort.

Common side effects (may affect up to 1 in 10 people):

Headache, dizziness, dizziness, pain and discomfort from the upper abdomen, nausea, vomiting, diarrhea, stomach cramps, indigestion, gas in the stomach, decreased appetite, skin rash and itching , changes in liver enzyme.

Uncommon side effects (may affect up to 1 in 100 people):

Palpitations, chest pain, heart failure , heart attack, bronchospasm , bleeding in the stomach and intestines, vomiting, dark blood containing feces or vomit, diarrhea, rash, liver inflammation or with jaundice, acute severe hypersensitivity reactions such as asthma , anaphylactic shock , low blood pressure , fluid accumulation in the body.

Rare side effects (may affect up to 1 in 1,000 people):

High blood pressure , anemia , decreased white blood cell count , decreased platelet count , drowsiness, pneumonia , asthma and difficulty breathing, inflammation of the gastric mucosa ( gastritis ), ulcers in the stomach or intestines that may be accompanied by bleeding or holes in the gastrointestinal wall, damage to the esophagus, inflammation and bleeding in the colon, worsening of Crohn’s disease or inflammatory bowel disease, cold sores, inflammation of the tongue, narrowing of the intestines, constipation, rash, severe skin reaction ( Stevens-Johnson syndrome), skin flaking ( toxic epidermal necrolysis ), red or purple discoloration of the skin (purpura and allergic purpura), hair loss, eczema , sensitivity to light, chronic severe inflammation of the liver, liver disease, jaundice, inflammation of the blood vessels, impotence (causal relationship with diclofenac is uncertain).

Very rare side effects (may affect up to 1 in 10,000 people):

Swelling of the face, lips, tongue or throat which can cause severe breathing difficulties ( angioedema ), stroke , numbness, impaired memory, irritation, cramps, depression, anxiety, nightmares, tremors, taste change, visual disturbance, hearing loss, tinnitus (ear noise), acute deterioration renal function, blood or protein in the urine, psychotic reactions, confusion, insomnia, inflammation of the kidneys, severe kidney disease ( nephrotic syndrome ) and damage to kidney tissue, meningitis with symptoms such as headache, stiff neck and fever (aseptic meningitis), dead liver cells (liver necrosis) , liver failure, inflammationin the pancreas, redness on the skin.

No known frequency (can not be calculated from the available data)

Chest pain, which may be a sign of a potentially serious allergic reaction such as cold Kounis syndrome. If you experience chest pain, talk to your doctor immediately.

For NSAIDs , severe skin and soft tissue infections are rare in rare cases

associated with chickenpox.

Reporting of side effects ar

If you get any side effects , talk to your doctor, pharmacist or nurse. This also applies to side effects that are not mentioned in this information. You can also report side effects directly via the Medical Products Agency, Box 26, 751 03 Uppsala, By reporting side effects , you can help increase the safety of medicines.

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. By reporting side effects, you can help increase drug safety information.

5. How to store Ignorin

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified 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 packaging and other information

Content declaration

Content declaration

  • The active substance is diclofenac potassium
  • The other ingredients are sodium starch glycolate , anhydrous colloidal silica, povidone, maize starch, anhydrous calcium hydrogen phosphate, magnesium stearate (E470b), polyvinyl alcohol, titanium dioxide (E171), talc (E553b), xanthan gum (E4), red (E415) iron oxide (E172)

What the medicine looks like and contents of the pack

Appearance:

Pink, round, biconvex, film-coated tablet, 6 mm in diameter.

Pack sizes:

Blister packs (Al / Al) containing 6, 10, 12, 20, 30, 50 and 100 tablets

PP jar with LDPE lid and desiccant containing 10, 20, 30, 50 and 100 tablets.

Not all pack sizes may be marketed

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Rivopharm Ltd.

17 Corrig Road

Sandyford, Dublin 18

Ireland

Manufacturer:

Specifar SA

1, 28 Octovriou str.

Agia Varvara, 12351, Athens

Greece

Coripharma ehf,

Reykjavíkurvegur 78,

IS-220, Hafnarfjörður

Iceland

Agent:

SanoSwiss UAB

Lvovo 25-701, LT-09320 Vilnius

Lithuania

info@sanoswiss.com

Muhammad Nadeem

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