Prospecto:Information for the Patient

Periactin 4 mg Tablets

ciproheptadina hydrochloride 1.5 hydrate

Read this prospectus carefully before starting to take this medication,because it contains important information for you.

Follow exactly the medication administration instructions contained in this prospectus or those indicated by your doctor or pharmacist.

• Keep this prospectus, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects,consult your doctor or pharmacist,eveniftheyare not listed in this prospectus. See section 4.
• You should consult a doctor if you worsen or do not improve.

1.What is Periactin and what is it used for

2.What you need to knowbeforestarting totake Periactin

3.How to take Periactin

4.Possible adverse effects

5Storage of Periactin

6.Contents of the package and additional information

Periactin contains the active ingredientciproheptadina hydrochloride 1,5 hydrate, a histamine antagonist that is used in adults and children over two years old for:

• symptomatic treatment of allergies (rhinitis, conjunctivitis, urticaria).
• complementary treatment of severe allergic reactions (anaphylactic reactions) after acute symptoms have been controlled.

You should consult a doctor if symptoms worsen or do not improve.

Do not take Periactin

• If you are allergic to ciproheptadina hydrochloride 1.5 hydrate or to any of the other components of this medication (listed in section 6).
• If you are allergic to drugs with a similar chemical structure to ciproheptadina (piperidines, such as donepezilo) or to other antihistamines.
• If you have closed-angle glaucoma
• If you are experiencing an acute asthma attack
• If you have ulcers that lead to narrowing of the stomach, small intestine, or esophagus (ulcerative peptic stenosis)
• If you have an enlarged prostate (prostatic hypertrophy)
• If you have a blockage of the bladder neck or a blockage of the valve that connects the stomach to the duodenum (piloroduodenal obstruction)
• If you are taking a treatment with monoamine oxidase inhibitors (see section 2 "other medications and Periactin")
• If you are breastfeeding your baby (see "Pregnancy and breastfeeding")
• Do not give this medication to a newborn or premature baby
• If you are elderly or have a weakened health, as you are more prone to experiencing drowsiness and low blood pressure with this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication:

• If you have a severe respiratory disease.
• If you have porphyria (a rare disorder, usually inherited, in which a large amount of porphyrin is eliminated in feces and urine)
• If you have a disease in which there is an abnormal increase in the activity of the thyroid gland (hyperthyroidism), high intraocular pressure, heart disease, or high blood pressure.
• If you are using a medication that produces ototoxicity, as the symptoms of these effects may be masked, such as tinnitus, dizziness, or vertigo.
• If you have any kidney disease or disorder

Antihistamines can decrease alertness; on the other hand, they can produce excitement, especially in small children.

Rarely, long-term treatment with antihistamines can cause alterations in blood cell counts.

Antihistamine treatment can mask the toxic effects of medications that produce ototoxicity.

Children and adolescents

This medication should not be used in newborns or premature babies (see "Do not take Periactin").

This medication is not recommended for children under 2 years of age because its efficacy and safety have not been established in this population.

Given the high sensitivity of children to antihistamines, the dose of ciproheptadina should be established with special caution in this group.

Other medications and Periactin

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Inform your doctor if you are taking:

• Monoamine oxidase inhibitors (MAOIs), such as, for example, moclobemide (used to treat depression) or selegiline, rasagiline (used to treat Parkinson's disease). These medications should not be taken at the same time as Periactin (see section 2 "Do not take Periactin").
• Medications that induce sleep and medications that reduce the activity of the central nervous system (hypnotics, sedatives, tranquilizers, anxiolytics). This medication may increase their effects.

• Selective serotonin reuptake inhibitors, such as, for example, fluoxetine, paroxetine, sertraline, citalopram, escitalopram (medications used to treat depression), as Periactin may cause a possible recurrence of depression and associated symptoms.

Periactin with food, drinks, and alcohol

Alcohol consumption should be avoided during treatment. Alcohol increases the effects of this medication.

Interference with diagnostic tests

If you are to undergo a pituitary function test, inform your doctor that you are taking this medication, as it may alter the result of the test.

If you are to undergo a test to determine tricyclic antidepressants in blood or urine, inform your doctor that you are taking this medication, as it may alter the result of the test.

Pregnancy and lactation

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Ciproheptadina should be used during pregnancy only if strictly necessary and under close medical supervision.

If you take this medication during the last three months of pregnancy, your baby may experience adverse effects.

This medication is contraindicated in mothers during lactation (see "Do not take Periactin"). The passage of ciproheptadina to breast milk is unknown. Due to the possibility of severe adverse effects in infants, your doctor will decide with you whether to interrupt breastfeeding or interrupt treatment.

Driving and operating machinery

This medication may cause drowsiness, which may affect your ability to drive and/or operate machinery. Patients should avoid operating hazardous machinery, including cars, until they know how they tolerate the medication.

This medication contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Adults

The recommended initial dose is 4 mg (1 tablet) three times a day; the dose should then be adjusted according to the patient's response. The recommended maintenance dose is 12 mg to 16 mg per day, divided into 3 doses. The dose should not exceed 32 mg per day, divided into 3 doses.

Use in children

Children aged 2 to 6 years:The recommended dose is 2 mg (half a tablet) two or three times a day, according to the patient's response. The total dose should not exceed 12 mg per day, divided into 3 doses.

Children aged 7 to 14 years:The recommended dose is 4 mg (1 tablet) two or three times a day, according to the patient's response. The total dose should not exceed 16 mg per day, divided into 3 doses.

Adolescents 15 years and older:The recommended initial dose is 4 mg (1 tablet) three times a day; the dose should then be adjusted according to the patient's response. The recommended maintenance dose is 12 mg to 16 mg per day, divided into 3 doses. The dose should not exceed 32 mg per day, divided into 3 doses.

The tablet can be divided into equal doses.

If you take more Periactin than you should

If you take more Periactin than recommended, you may experience hallucinations, decreased or increased functions of the central nervous system, convulsions, respiratory and cardiac arrest, and death, especially in children.

Other symptoms may also appear, such as gastrointestinal symptoms and other symptoms like dry mouth, hot flashes, and dilated pupils.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 91-562 04 20, indicating the medication and the amount ingested.

If you forget to take Periactin

Do not take a double dose to make up for the missed dose.

If you have any other questions about the use of thismedication, ask your doctororpharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The side effects that appear frequently are drowsiness and a tendency to sleep. Many patients who experience drowsiness at the beginning of treatment recover to normal after 3 or 4 days of treatment.

During the period of use of ciproheptadine, the following adverse reactions have been reported, whose frequency has not been established with precision:

• hemolytic anemia, decrease in white blood cells, decrease in granulocytes, decrease in platelets
• allergic edema (swelling of the face, lips, mouth, tongue, or throat), anaphylactic shock (severe allergic reaction)
• increased appetite, decreased appetite
• agitation, confusion, feeling disconnected from oneself, thoughts, feelings, and surroundings, euphoria, hallucinations, insomnia, irritability, nervousness, restlessness
• sedation, drowsiness, dizziness, coordination disorders, tremors, numbness, tingling, or burning sensation (paresthesia), nerve inflammation, seizures, syncope, headache
• inner ear inflammation (labyrinthitis), blurred vision, double vision, vertigo, ringing in the ears (tinnitus)
• palpitations, tachycardia (rapid heartbeat), extrasystoles (premature heartbeats)
• low blood pressure
• nasal dryness, throat dryness, thickened bronchial secretions, chest oppression, wheezing (respiratory sounds with audible clicks), sneezing, nasal congestion
• dry mouth, stomach discomfort, nausea, vomiting, diarrhea, constipation
• jaundice (yellow discoloration of skin and mucous membranes), increased transaminases in blood
• allergic dermatitis, excessive sweating, urticaria, increased skin sensitivity to sunlight and ultraviolet light (photosensitivity)
• increased urination, difficult urination, urinary retention
• premature menstruation
• fatigue, chills, tiredness
• weight gain

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. Deposit the packaging and medications that you no longer need at the SIGRE collection point at the pharmacy. In this way, you will help protect the environment.

Composition of Periactin

• The active ingredient is ciproheptadine hydrochloride 1.5 hydrate. Each tablet contains 4 mg of ciproheptadine hydrochloride 1.5 hydrate.
• The other components (excipients) are lactose monohydrate, carboxymethylcellulose sodium (type A) (from potato), magnesium stearate, and dibasic calcium phosphate dihydrate.

Appearance of the product and contents of the packaging

Periactin are white, round, scored tablets on one face and with the sigma symbol and the number 62 engraved on the other.

They are presented in packs of 30 tablets.

Marketing Authorization Holder

Alfasigma España, S.L

Avda. Diagonal, 490

08006 Barcelona. SPAIN

Responsible for Manufacturing

Pharmaloop, S.L

C/Bolivia, 15- Industrial Estate Azque

28806 Alcalá de Henares (Madrid). SPAIN

or

Alfasigma S.p.A

Via Pontina Km 30,400

00071 Pomezia, Rome. ITALY

Last revision date of this prospectus: February 2023.

Other sources of information

The detailed information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/ .