Ipren 200 mg film coated ibuprofen Tablets
1. What Ipren Is And What Is Ipren Used For
Ipren belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory / anti-rheumatic medicines).
Ipren tablet is analgesic, antipyretic and anti-inflammatory.
Ipren tablets are used for temporary mild to moderate pain conditions such as
- Headaches
- Toothaches
- Muscle
- Joint pain
- Back pain
- Menstrual cramps
- Fever in colds
Ipren tablets usually work within 30 minutes and the maximum effect is reached within 1-2 hours. The analgesic effect lasts for up to 8 hours after taking 2 tablets (maximum single dose for adults and adolescents over 12 years).
Ipren ibuprofen contained may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
2. What you need to know before taking Ipren
Do Not Take Ipren
- If you are allergic to ibuprofen or any of the other ingredients of ipren tablet (listed in section 6).
- During the last three months of pregnancy
- If you have any disease with an increased tendency to bleed
- If you have severe liver or kidney disease
- If you have severe heart failure
- If you have or have had stomach ulcers or duodenal ulcers, or have previously had stomach ulcers or duodenal ulcers during treatment with Ipren 200 mg or similar preparations
- If you have had allergic symptoms
- Difficulty breathing
- Nasal congestion
- Rash while taking acetylsalicylic acid or similar medicines for inflammation
- If you are about to undergo or have recently undergone, heart surgery
Warnings And Cautions
Ipren ibuprofen can cause severe allergic reactions, especially if you are allergic to acetylsalicylic acid. Symptoms may include
- Hives
- Swelling of the face
- Asthma (wheezing or wheezing)
- Shock
- Flushing
- Rash
- Blisters with or without fever
If you get any of these symptoms, stop taking ipren 200 mg and contact a doctor immediately.
Serious skin reactions have been reported during treatment with it. You should stop taking Ipren immediately and seek medical attention if you develop any
- Rash
- Sores on the mucous membranes
- Blisters
- Other signs of allergy
As these may be the first signs of a very serious skin reaction. See section 4.
The lowest dose and shortest possible treatment time should always be sought to reduce the risk of side effects. A higher dose than recommended can lead to serious risks. Do not use different types of painkillers at the same time without a doctor’s prescription.
You should discuss your treatment with a doctor or pharmacist before taking Ipren if you:
- Have heart problems including
- Heart failure
- Angina (chest pain) or if you have had a heart attack
- Bypass surgery
- Peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked blood vessels) or some form of stroke (including “mini-stroke”) or transient ischemic attack ( TIA )).
- Have
- High blood pressure
- Diabetes
- High cholesterol
- A history of heart disease or stroke in the family or if you are a smoker.
- Have fluid retention in the body ( edema )
- Have or have had the following diseases or symptoms:
- SLE or other connective tissue diseases
- Impaired renal or hepatic function
- Asthma
- Inflammatory bowel disease, previous gastric ulcer, or other increased tendencies to bleed.
Infection is
Ipren can hide signs of infection such as fever and pain. Therefore, ipren 200 mg may delay the appropriate treatment of infection and increase the risk of complications. This has been observed in pneumonia caused by bacteria and in bacterial skin infections associated with chickenpox. If you are taking ipren tablet while you have an infection and the symptoms of infection persist or worsen, you should contact your doctor.
- Adults: You must talk to a doctor if you do not feel better or if you feel worse after 3 days with a fever and after 5 days with pain.
- Adolescents over 12 years of age: Contact a doctor if adolescents need to use ipren dosis for more than 3 days, or if their symptoms worsen.
For chickenpox, Ipren should not be used.
If you have previously had problems with the gastrointestinal tract, you should contact a doctor if you have symptoms from the abdomen. Contact with a doctor is especially important if the symptoms occur at the beginning of treatment and in elderly patients.
Elderly people should be aware of the increased risk of side effects that exist in old age.
Anti-inflammatory/analgesic drugs such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when using high doses.
Do not exceed the recommended dose or treatment time (3 days for fever and 5 days for pain).
Ipren can affect the possibility of getting pregnant, see the section Pregnancy and breastfeeding for more information.
Children And Adolescents:
Ipren tablets should not be given to children under 6 years of age
| Contact a doctor before using Ipren if: the child is difficult to carry or has abdominal pain, stiff neck, or back pain. the child has severe problems with the ears, throat, or trachea. If the child has a fever contact a doctor if the child has not drunk any fluid or lost a large amount of fluid due to vomiting, diarrhea, or high fever. This increases the risk of dehydration. the treatment did not have any effect on the pain or fever after the first day. new symptoms appear or stomach pain/stomach upset worsens or lasts a long time. |
There is a risk of impaired kidney function in children and adolescents who are dehydrated.
Other Medicines And Ipren
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not use different types of painkillers at the same time without a doctor’s prescription.
Ipren can affect or be affected by treatment with certain drugs, for example against:
- Tumor er and disorders of the immune system (methotrexate)
- Manic depressive illness (lithium)
- Irregular heartbeat ( digoxin )
- Pain ( acetylsalicylic acid )
- Blood clots such as
- Blood thinners
- Acetylsalicylic acid
- Dicumarol
- Warfarin
- Ticlopidine
- Depression (so-called SSRIs )
- High blood pressure ( ACE inhibitors eg
- Captopril
- Beta-blockers eg atenolol
- Angiotensin II receptor antagonists eg losartan
- Inflammation ( corticosteroids are)
- Fungal infections (eg voriconazole and fluconazole )
- Diabetes (sulphonylureas)
- HIV – infection (zidovudine)
- Certain immunosuppressive drugs against rejection of transplanted organs (eg cyclosporine, tacrolimus)
Some other medicines may also affect or be affected by treatment with Ipren. You should therefore always consult your doctor or pharmacist before using Ipren with other medicines.
Ipren With Food, Drink, And Alcohol
Ipren can be taken with food and drink. Ipren works faster if the tablet is taken on an empty stomach. The risk of bleeding in the gastrointestinal tract may increase if you drink alcohol.
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 ipren tablet.
Pregnant women should not use Ipren during the last three months of pregnancy.
zzIpren should be avoided by women who are planning to become pregnant or are pregnant. Treatment during any part of the pregnancy should only be done after a doctor’s prescription.
Ipren passes into breast milk but is unlikely to affect breastfed infants. Consult a physician if you need more than temporary use of Ipren during breastfeeding.
Treatment with ibuprofen may affect the ability to conceive. This effect is temporary and ceases if the medication is stopped. Ibuprofen is not recommended for women who want to become pregnant or undergo infertility tests.
Driving And Using Machines
It may impair the ability of some people to react, for example, due to side effects such as visual disturbances. This should be borne in mind at times when sharper attention is required, for example when driving a car.
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.
Ipren Contains Sodium
It contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free.
3. How To Take Ipren
Always use ipren 200 mg exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The lowest effective dose should be used for the shortest possible time to relieve symptoms. Contact a doctor if you have an infection and the symptoms (such as fever and pain) persist or worsen (see section 2).
Adults: Contact a doctor if symptoms worsen or do not improve within 3 days in case of fever and within 5 days in case of pain.
Children and adolescents: Contact a doctor if children and adolescents need to use ipren tablet for more than 3 days, or if their symptoms worsen.
Occasional mild to moderate pain and fever in colds
Adults and adolescents over 12 years (over 40 kg):
The maximum daily dose should not exceed 6 tablets (total of 1,200 mg). Dose and be taken as:
- 1 tablet if needed 1-4 times a day at least 4-6 hours apart.
- 2 tablets if needed 1-3 times a day at least 4-6 hours apart.
- More than 2 tablets at a time do not provide a better analgesic effect.
Children 6-12 years (over 20 kg): 1 tablet if needed 1-3 times a day at least 4-6 hours apart.
The maximum daily dose should not exceed 3 tablets.
Menstrual pain
Adults and adolescents over 12 years (over 40 kg): 2 tablets if necessary 1-3 times a day at least 4-6 hours apart. The maximum daily dose should not exceed 6 tablets (total of 1,200 mg). Take the medicine as early as possible at the beginning of menstruation, then the effect will be better. More than 2 tablets at a time do not provide a better analgesic effect.
If You Take More Ipren Than You Should
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
Symptoms may include
- Nausea
- Stomach pain
- Vomiting (with blood)
- Headache
- Ringing in the ears
- Confusion
- Jerky involuntary eye movements
- At high doses
- Drowsiness
- Chest pain
- Palpitations
- Unconsciousness
- Seizures (mainly in children)
- Weakness and dizziness
- Blood in the urine
- Chills
- Difficulty breathing
has been reported
The symptoms usually come within 4 hours.
If You Forget To Take Ipren
Do not take a double dose to make up for a forgotten tablet.
4. Possible Ipren Side Effects
Like all medicines, ipren can cause side effects, although not everybody gets them.
Stop taking Ipren and contact a doctor immediately if you experience any of the following symptoms ( angioedema, affects less than 1 in 100 people):
• Swelling of the face, tongue, or throat
• Difficulty swallowing
• Hives and difficulty breathing severe skin reactions when using NSAIDs have been reported in very rare cases.
Stop taking ipren tablets and consult a doctor if you get a rash or damage to the mucous membranes.
A severe skin reaction called DRESS syndrome can occur. Symptoms of DRES include
- Rash
- Fever
- Swollen lymph nodes
- An increase in eosinophils (a type of white blood cell )
- Widespread red
- Scaly rash with lumps under the skin and blisters mainly in the folds of the skin
- On the torso and arms together with fever at the beginning of treatment ( acute generalized exanthematous pustulosis )
have been reported. Stop using Ipren immediately if you develop these symptoms and seek medical attention immediately. See also section 2.
Other side effects may occur
Common ipren side effects (affects more than 1 user in 100):
- Headache
- Dizziness
- Somnolence
- Gastrointestinal side effects
- Heartburn
- Diarrhea
- Nausea
- Vomiting
- Abdominal pain
- Rash
- Impotence
Uncommon ipren side effects (affects less than 1 user in 100):
- Insomnia
- Anxiety
- Impaired vision
- Impaired hearing
- Bleeding such as nosebleeds and blood in the urine, prolonged bleeding time
- Asthma
- Allergic rhinitis
- Constipation
- Inflammation
- Sores
- Bleeding in the gastrointestinal tract
- Angioedema (sudden swelling eg in the face or tongue)
- Hives
- Itching
- Slight bleeding in the skin and mucous membranes
Rare ipren tablet side effects (affects less than 1 in 1,000 people):
- Non-bacterial meningitis
- Soft-tissue infections associated with chickenpox
- Blood count changes
- Allergic reaction
- Hypersensitivity
- Fluid accumulation in the body
- Confusion
- Depression
- Stroke
- Powerful drive to be physically active with simultaneous mental anxiety (psychomotor hyperactivity)
- Visual impairment
- Blurred vision
- Heart failure
- Heart attack
- High blood pressure
- Cramps in the trachea
- Bleeding or ruptured stomach ulcer
- Crohn’s disease
- Burning sensation or irritation of the mouth
- Inflammation in the pancreas
- Liver and kidney effects
- Skin and mucosal effects (sometimes severe) such as epidermal detachment and/or multiple skin redness
- Stevens-Johnson syndrome (an extremely severe allergic reaction with skin rash usually in the form of blisters or sores in the oral cavity and eyes as well as other mucous membranes such as the genitals)
- Lowered body temperature
Very rare ipren side effects (affects less than 1 user in 10,000):
- Flatulence
- Scaly
Has been reported (occurs in an unknown number of users):
- Clearly defined
- A reddened rash with or without blisters that reappear in the same place on the skin or mucous membrane with repeated use of ibuprofen, even mild itching may occur (fixed drug rash); the skin becomes photosensitive.
Reporting of ipren 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 Ipren
- Keep ipren out of the sight and reach of children.
- Do not use ipren tablet after the expiry date which is stated on the carton after EXP. dat. 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
- The active substance is ibuprofen . 1 tablet contains 200 mg ibuprofen .
- The other ingredients are anhydrous colloidal silica, magnesium stearate, croscarmellose sodium, microcrystalline cellulose, hypromellose, polydextrose (E1200), and polyethylene glycol 4000.
What The Ipren Looks Like And Contents Of The Pack
- The tablets are white, round, and slightly arched.
- One pack contains 30 tablets.
- Not all pack sizes may be marketed.
Marketing Authorisation Ho
Tel: 08-503 385 00
med-info@its.jnj.com