2 mg tablets
Loperamide hydrochloride
What Loperamide Apofri is and what it is used for
Loperamide Apofri normalizes bowel movements, counteracts fluid loss, and increases the ability to hold stools.
Loperamide Apofri is used for temporary ( acute ) diarrhea in adults and adolescents over 12 years of age.
Loperamide hydrochloride contained in Loperamide Apofri may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Loperamide Apofri
Do not take Loperamide Apofri
- if you are allergic to loperamide or any of the other ingredients of this medicine (listed in section 6).
- in case of blood in the stool or in case of high fever ( acute dysentery).
- in inflammation of the colon (eg ulcerative colitis or pseudomembranous colitis caused by antibiotics ).
- in inflammation of the small and large intestine caused by bacteria ( Salmonella , Shigella and campylobacter ).
- if the passage of food through the intestine is already slow, for example if you are constipated or bothered by a tense stomach.
Loperamide Apofri should not be given to children under 12 years of age.
Warnings and cautions
- Treatment with Loperamide Apofri relieves symptoms but does not cure the cause. 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 consult a doctor.
- If you have impaired liver function, you should consult a doctor before starting treatment with Loperamide Apofri.
- With 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 taking Loperamide Apofri at the first sign of a tense abdomen.
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, the active substance in Loperamide Apofri.
Children
Loperamide Apofri should not be given to children under 12 years of age.
Other medicines and Loperamide Apofri
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Some medicines can affect or be affected by treatment with Loperamide Apofri 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 ( antifungal agents),
- oral desmopressin (agents used to control thirst and urine output in patients with diabetes insipidus and bedwetting in children and nocturnal urination in adults)
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
Experience with use during pregnancy is limited.
Breast-feeding
Loperamide Apofri 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 Loperamide Apofri.
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
Loperamide Apofri tablets contain lactose
Loperamide Apofri tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to use Loperamide Apofri
Always use this medicine exactly as described in this leaflet or as your doctor advised. Ask your doctor or pharmacist if you are unsure.
Recommended dose:
In case of temporary diarrhea:
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 Loperamide Apofri for a maximum of 2 days straight. Doctors may prescribe another dosage.
In chronic diarrhea:
Dose one is determined by the doctor who adjusts it individually for you.
The usual dose for adults and adolescents from 12 years: 1-8 tablets/day. Take a maximum of 8 tablets.
The tablets should be swallowed with half a glass of water.
Use in children
Loperamide Apofri should not be given to children under 12 years of age.
If you use more Loperamide Apofri than you should
If you take more Loperamide Apofri then you should contact your doctor or hospital immediately for advice. Symptoms of overdose may include increased heart rate, irregular heartbeat, changes in a heartbeat (these symptoms can potentially have serious, life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating, and weak breathing.
Children react more strongly than adults to large amounts of Loperamide Apofri. Contact a doctor immediately if a child has ingested too much of the medicine or has any of the above symptoms.
You must talk to a doctor if you do not feel better or if you feel worse after 2 days.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Loperamide Apofri and contact your doctor immediately if you get any of the following rare symptoms:
- 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.
- Lyell´s 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 (affects more than 1 user in 100): constipation, nausea, flatulence/gas, headache, and dizziness.
Uncommon (affects less than 1 user in 100): drowsiness, abdominal pain or discomfort, dry mouth, vomiting, indigestion, and rash.
Rare (affects less than 1 in 1,000 people): hypersensitivity reactions such as anaphylactic shock, muscle stiffness, small pupils, itching, hives, and difficulty urinating.
How to store Loperamide Apofri
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/blister. The expiration date is the last day of the specified month.
Medicines thing not thrown in the drain or among the household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures are to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is loperamide hydrochloride 2 mg
- The other ingredients are: anhydrous lactose , maize starch, polysorbate 80, talc, anhydrous colloidal silica and, magnesium stearate.
What the medicine looks like and contents of the pack
Tablets 2 mg: white and round, one side marked L2.
Available in blister packs of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and 16 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Apofri AB, Box 120, 182 12 Danderyd
Manufacturer
Evolan Pharma AB, Svärdvägen 19, 182 33 Danderyd