Imolopera 2 mg loperamide hydrochloride tablets
1. what Is Imolopera And What Imolopera Used For
Imolopera normalizes bowel movements, counteracts fluid loss, and increases the ability to hold stools. Imolopera is used for temporary ( acute ) diarrhea in adults and adolescents over 12 years of age. Loperamide hydrochloride contained in Imolopera 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. You must talk to a doctor if you do not feel better or if you feel worse after 2 days.
2. What You Need To Know Before You Use Imolopera
Do Not Use Imolopera
- If you are allergic to loperamide or any of the other ingredients of this medicine (listed in section 6).
- In the case of blood in the stool or in case of high fever (intestinal infection caused by bacteria such as Salmonella , Shigella and Campylobacter )
- In inflammation of the colon (eg ulcerative colitis or pseudomembranous colitis caused by antibiotics )
- If the passage of food through the intestine is already slow, e.g. if you are constipated or bothered by a distended abdomen
Imolopera should not be given to children under 12 years of age.
Warnings And Cautions
Talk to your doctor, pharmacist, or nurse before taking Imolopera.
- If temporary diarrhea has not stopped after two days of treatment, stop treatment and consult a doctor.
- In case of signs of constipation or other signs of impaired bowel passage, stop treatment and contact a doctor.
- If you have impaired liver function, you should consult a doctor before starting treatment with Imolopera.
- In diarrhea you lose a lot of fluid. It is therefore important that you compensate for the fluid loss by drinking a lot.
- If you have AIDS , stop treatment with Imolopera at the first sign of a tense abdomen.
Treatment with Imolopera relieves symptoms but does not cure the cause. Do not take this medicine for anything other than its intended use (see section 1) and never take more than the recommended dose (see section 3).
Severe heart problems (with symptoms such as rapid or irregular heartbeat) have been reported in patients who have taken too much loperamide hydrochloride, the active substance in Imolopera.
Children
Imolopera should not be given to children under 12 years of age.
Other Medicines And Imolopera
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Some medicines can affect or be affected by treatment with Imolopera if taken at the same time. Examples of such drugs are:
- Cholestyramine and gemfibrozil (lipid lowering)
- Quinidine (for heart rhythm disorders and malaria )
- Ritonavir (for HIV / AIDS)
- Ciclosporin (inhibits the immune system)
- Verapamil (lowering blood pressure)
- Erythromycin and clarithromycin ( antibiotics )
- Itraconazole and ketoconazole (for fungal infections)
- Oral desmopressin (agents used to control thirst and urine output in patients with diabetes insipidus and bedwetting in children and nocturnal urination in adults)
Imolopera With Food And Drink
Imolopera can be taken with food and drink.
Pregnancy And Breastfeeding
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.
Pregnancy
There is only limited experience of use during pregnancy.
Breast-feeding
Imolopera is not recommended if you are breastfeeding as small amounts of the medicine may pass into breast milk.
Driving And Using Machines
Fatigue, dizziness, and drowsiness may occur during treatment with Imolopera.
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.
Imolopera Contains Lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How To Use Imolopera
- Always take this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse. If you are not sure, talk to your doctor, pharmacist, or nurse.
- The recommended dose is:
- Adults and adolescents from 12 years: Start with 2 tablets. If diarrhea has not stopped within 2-3 hours, take 1 tablet at a time after each loose stool. Take a maximum of 8 tablets per day. Take Imolopera for a maximum of 2 days straight. Doctors may prescribe another dosage.
- Use for children:
- Imolopera should not be given to children under 12 years of age.
- The tablets should be swallowed with liquid.
- The diarrhea-reducing effect is achieved within one hour after taking 2 tablets (4 mg).
If You Use More Imolopera Than You Should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice
If you take more Imolopera than you should, contact your doctor or hospital immediately for advice. Symptoms may include
- Increased heart rate
- Irregular or altered heartbeat (these symptoms may have serious, potentially life-threatening consequences)
- Muscle stiffness
- Uncoordinated movements
- Drowsiness
- Difficulty urinating
- Weak breathing
- Children react more strongly than adults to large amounts of Imolopera. Contact a doctor immediately if a child has ingested too much of the medicine or has any of the above symptoms.
If You Forget To Use Imolopera
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible Imolopera Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Imolopera and contact a doctor immediately if you get any of the following rare side effects:
- Swelling of the face, tongue or throat, difficulty swallowing or hives and difficulty breathing. This is a sign of angioedema.
- Extreme fatigue, coordination problems and loss of consciousness or loss of consciousness.
- Severe abdominal pain and / or swollen stomach which may be a sign of blocked or enlarged bowel.
- Lyellas syndrome ( toxic epidermal necrolysis ): Severe widespread skin damage (dermal detachment of the epidermis and superficial mucous membranes).
- 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 genitals.
The following side effects have been reported:
Common ( may affect more than 1 in 10 people):
- Constipation
- Nausea
- Flatulence/gas
- Headache
- Dizziness
Uncommon ( may affect up to 1 in 100 people):
- Drowsiness
- Abdominal pain or discomfort
- Dry mouth
- Vomiting
- Indigestion and rash
Rare (may affect up to 1 in 1,000 people):
- Hypersensitivity reactions such as
- Anaphylactic shock
- Muscle stiffness
- Small pupils
- Itching
- Hives
- Difficulty urinating
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 Imolopera
- 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
- The active substance is:
- Loperamide hydrochloride 2 mg
- The other ingredients are:
- Anhydrous lactose 101 mg
- Corn starch
- Polysorbate 80
- Talc
- Collodial
- Anhydrous silica
- Magnesium stearate
What The Medicine Looks Like And Contents Of The Pack
- Tablets are white and round with a diameter of 6.5 mm, one side marked C and the other side marked 11.
- Blister packs: 16 tablets.
Marketing Authorization Holder And Manufacturer
Orifarm Generics A / S
Energivej 15
5260 Odense S
Denmark
Local representative:
Orifarm Generics AB
Box 56048
102 17 Stockholm
info@orifarm.com