Peritol

Package Leaflet: Information for the User

Peritol, 4 mg, Tablets

Cyproheptadine Hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, 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 pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Peritol and what is it used for
• 2. Important information before taking Peritol
• 3. How to take Peritol
• 4. Possible side effects
• 5. How to store Peritol
• 6. Contents of the pack and other information

1. What is Peritol and what is it used for

Cyproheptadine, the active substance of Peritol, belongs to a group of medicines called antihistamines. It blocks the action of histamine and other substances produced by the body that cause allergy or itching. It is a serotonin and histamine antagonist. Peritol is used to treat allergic diseases, especially those accompanied by itching, e.g. acute and chronic urticaria, angioedema, drug rash, eczema, atopic dermatitis, contact dermatitis, neurodermatitis, allergic rhinitis (hay fever), vasomotor rhinitis, serum sickness, local allergic reactions occurring after insect bites, in vascular headaches (migraine, histamine-dependent headaches), in patients with anorexia nervosa.

2. Important information before taking Peritol

When not to take Peritol

• if you are allergic to cyproheptadine or any of the other ingredients of this medicine (listed in section 6),
• if you have an acute asthma attack,
• if you have glaucoma,
• if you have a narrowing of the stomach and small intestine, causing vomiting of un digested food, as in stomach ulcers in a specific location,
• if you have symptomatic prostatic hypertrophy or narrowing of the neck of the bladder, accompanied by urinary retention,
• if you are taking monoamine oxidase inhibitors (MAOIs),
• if you are pregnant, trying to become pregnant or breastfeeding,
• in newborns and infants,
• in patients who are debilitated, including the elderly (over 65 years of age).

Warnings and precautions

If you have any of the following diseases, you should discuss this with your doctor before starting Peritol:

• asthma in your medical history,
• increased intraocular pressure,
• hyperthyroidism,
• heart and circulatory system disease,
• hypertension.

When taking Peritol for the first time, you should take the medicine after dinner, as it may cause drowsiness. Always inform your doctor if any of the following symptoms occur during Peritol treatment: fever, sore throat, oral ulcers, pallor, yellowing of the skin and whites of the eyes, bruising, untypical or uncontrollable bleeding. In such cases, your doctor may order certain laboratory tests. If the results of these tests indicate that the disorders are caused by the administration of the medicine, your doctor may consider discontinuing Peritol treatment. Always follow your doctor's instructions.

Children and adolescents

Peritol should not be used in children under 2 years of age. Do not give any medicines to children without consulting a doctor. If your doctor has prescribed Peritol for your child, make sure the medicine is used in accordance with the doctor's instructions. In some children, restlessness may occur during treatment. Tell your doctor if you think your child's behavior is related to the medicine being taken.

Peritol and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take. Medicines used to treat depression (e.g. phenelzine, selegiline, moclobemide) enhance and prolong the action of Peritol. Sedatives, tranquilizers, and anxiolytics enhance the sedative effect of Peritol. Peritol may interfere with the action of serotonin reuptake inhibitors. This can lead to a relapse of depression and related symptoms. Cyproheptadine may cause a false positive result in the test for the presence of tricyclic antidepressants during a urine screening test for drugs. If such a test is planned, you must inform your doctor about taking Peritol. Therefore, be particularly careful if you are taking any of these medicines at the same time as Peritol. If you have any doubts about the medicines you are taking, consult your doctor.

Peritol with alcohol

Do not drink alcoholic beverages while taking this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Taking this medicine is contraindicated during pregnancy and breastfeeding.

Driving and using machines

Especially at the beginning of Peritol treatment, it may cause dizziness, drowsiness, and psychomotor slowing. Therefore, during the initial phase of treatment - for a period to be determined individually - do not drive vehicles or operate machines. In the later phase of treatment, restrictions and prohibitions on driving vehicles and operating machines will be determined by your doctor individually for each patient.

Peritol contains lactose

Each Peritol tablet contains 128 mg of lactose. If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Peritol

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor. AdultsThe recommended initial dose is 12 mg (1 tablet 3 times a day). In chronic urticaria, the medicine can be taken in a total daily dose of 6 mg (3 times half a tablet). In acute migraine attacks, the recommended dose is 4 mg (1 tablet) once a day. If the migraine headache persists after half an hour, the dose can be repeated. Remember not to exceed the dose of 8 mg (2 tablets) within 4 to 6 hours. In anorexia nervosa, the recommended dose is 4 mg (1 tablet) 3 times a day. Maintenance dose: the total daily dose of 12 mg (1 tablet 3 times a day) is usually sufficient. Maximum daily dose: 20 mg (5 tablets). The use of Peritol in the elderly and (or) debilitated is contraindicated, as this group of patients may be particularly prone to certain side effects characteristic of antihistamines (e.g. dizziness, drowsiness, hypotension).

Use in children and adolescents

Peritol is not recommended for children under 2 years of age. The recommended dose for children over 2 years of age is 0.25 mg/kg body weight per day, i.e. 8 mg/m2 body surface area. Children aged 2 to 6 years: the recommended initial daily dose is 2 mg twice or three times a day (half a tablet 2 or 3 times a day) adjusted to the patient's weight and clinical response. If an additional dose is needed, it should be given before bedtime. The maximum daily dose in this age group is 8 mg (2 tablets). Children aged 7 to 14 years: the recommended daily dose is 8 to 12 mg (2 or 3 times 1 tablet). If an additional dose is needed, it should be given before bedtime. The maximum daily dose in this age group is 16 mg (4 tablets). Children aged 15 to 18 years: there are no data on the use of cyproheptadine in children aged 15-18 years. Patients with liver function disorders: due to the possibility of reduced metabolism of the active substance, your doctor may recommend a dose reduction. Patients with kidney function disorders: the excretion of the medicine is mainly through the kidneys, so your doctor may recommend a dose reduction. Your doctor will tell you how long the treatment with Peritol will last. You should take Peritol at about the same time every day. This will be most beneficial and will also help you remember to take the tablets. If you feel that the effect of Peritol is too strong or too weak, consult your doctor.

Overdose of Peritol

In case of taking a higher dose of Peritol than recommended, or if someone else has taken the medicine by mistake, go to the emergency department of the nearest hospital. Bring this leaflet and all the remaining tablets to show them to the doctor. Symptoms of overdose: excessive sedation, drowsiness, coma, excitement and convulsions, dryness of the mouth, stiff dilation of the pupils, flushing of the skin, as well as gastrointestinal symptoms. Treatment: in case of suspected overdose of Peritol, vomiting should be induced, gastric lavage performed, activated charcoal administered, and supportive treatment used. The use of osmotic laxatives that draw water into the intestines and dilute their contents may be helpful. Avoid administering central nervous system stimulants. Hypotension should be treated with vasoconstrictor agents.

Missing a dose of Peritol

Do not take a double dose to make up for a missed dose. If you have any further questions about taking the medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following symptoms, stop taking Peritol and contact your doctor or emergency services, or go to the emergency department of the nearest hospital:

• allergic reaction (due to hypersensitivity), skin rash, urticaria, swelling of hands, feet or face,
• severe hypersensitivity reaction with difficulty breathing, dizziness. In rare cases, long-term treatment with Peritol may cause hematological disorders (significant reduction in white blood cell count leading to weakened immunity to infectious diseases, reduction in platelet count, hemolytic anemia). You should see a doctor as soon as possible if you experiencefever, sore throat, oral ulcers, pallor, jaundice, fainting, breathing difficulties, petechiae, untypical or persistent bleeding during long-term treatment.

In addition, the following symptoms may occur during Peritol treatment:

• -loss of appetite or increased appetite.
• -disorientation, visual hallucinations, restlessness, irritability, nervousness, aggressive behavior, insomnia, euphoria, hysteria.
• -drowsiness; this is usually a transient side effect that often resolves after the first 3-4 days of treatment.
• excessive sedation, dizziness, coordination disorders, tremors, numbness, neuropathy (manifested by increased pain, inability to move, convulsions), convulsions, headaches, weakness.
• -blurred vision, accommodation disorders of the eye (pupil dilation), double vision.
• -acute inner ear inflammation, dizziness with a spinning sensation, tinnitus.
• -accelerated or irregular heartbeat, palpitations.
• -hypotension.
• -dryness of the nose and throat, presence of thick bronchial secretions, breathing difficulties, feeling of nasal congestion, nosebleeds.
• -dry mouth, nausea, vomiting, abdominal pain, diarrhea and constipation.
• -yellowing of the skin and eyes, sometimes with fever, discolored stools, and dark urine. Such symptoms suggest liver disease, bile duct obstruction, hepatitis, or liver failure.
• -skin rash, excessive sweating, photosensitivity.
• -frequent urination, difficulty urinating, urinary retention.
• -early menstruation.
• -chest tightness, fatigue, chills.
• -weight gain.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Peritol

Store below 25°C. Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the packaging. Expiry date (EXP) Batch number (Lot) Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Peritol contains

• The active substance of Peritol is cyproheptadine hydrochloride. Each tablet contains 4 mg of cyproheptadine hydrochloride (equivalent to 4.3 mg of cyproheptadine hydrochloride hemihydrate).
• The other ingredients are: gelatin (type B), lactose monohydrate, magnesium stearate, potato starch, talc.

What Peritol looks like and contents of the pack

White or grayish-white, round, flat, beveled tablets with a dividing line on one side and the inscription "PERITOL" on the other side. The tablet can be divided into equal doses. PVC/PVdC/Al blisters in a cardboard box, with an enclosed patient information leaflet. The pack contains 20 tablets (2 blisters of 10 tablets each).

Marketing authorization holder:

Egis Pharmaceuticals PLC, 1106 Budapest, Keresztúri út 30-38, Hungary

Manufacturer:

Egis Pharmaceuticals PLC, Mátyás király u. 65, 9900 Körmend, Hungary To obtain more detailed information, please contact the representative of the marketing authorization holder in Poland.EGIS Polska Sp. z o.o., ul. Komitetu Obrony Robotników 45D, 02-146 Warsaw, Phone: +48 22 417 92 00

Date of last revision of the leaflet: 29.01.2024