PERIACTIN 4 mg TABLETS

2. What you need to know before taking Periactin

Do not take Periactin

• If you are allergic to ciproheptadine 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 ciproheptadine (piperidines, such as donepezil) or to other antihistamines.
• If you have narrow-angle glaucoma
• If you are having an acute asthma attack
• If you have intestinal ulcers that lead to narrowing of the stomach, small intestine, or esophagus (peptic ulcer stenosis)
• If you have an enlarged prostate (prostatic hypertrophy)
• If you have an obstruction of the neck of the bladder or an obstruction of the valve that connects the stomach to the duodenum (pyloroduodenal obstruction)
• If you are undergoing treatment with monoamine oxidase inhibitors (see section 2 "Other medications and Periactin")
• If you are breastfeeding (see "Pregnancy and lactation")
• Do not give this medication to a newborn or premature baby
• If you are elderly or in poor 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, usually inherited disorder 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 thyroid gland activity (hyperthyroidism), high intraocular pressure, heart disease, or high blood pressure.
• If you are using any medication that causes ear toxicity, as symptoms of those toxic effects, such as ringing in the ears, dizziness, or vertigo, may be masked.
• If you have any kidney disease or disorder

Antihistamines can decrease alertness; on the other hand, they can sometimes cause excitement, especially in young children.

Rarely, prolonged treatment with antihistamines can cause changes in blood cell counts.

Treatment with antihistamines can mask the toxic effects of medications that cause ear toxicity.

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 ciproheptadine should be established with special caution in this group.

Other medications and Periactin

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

Tell your doctor if you are taking:

• Monoamine oxidase inhibitors (MAOIs), such as 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 fluoxetine, paroxetine, sertraline, citalopram, escitalopram (medications used for depression), as Periactin may cause a possible recurrence of depression and associated symptoms.

Taking 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 going to have 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 going to have 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 breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Ciproheptadine 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 side effects.

This medication is contraindicated in breastfeeding mothers (see "Do not take Periactin"). It is unknown whether ciproheptadine passes into breast milk. Due to the possibility of serious side effects in infants, your doctor will decide with you whether to interrupt breastfeeding or treatment.

Driving and using machines

This medication may cause drowsiness, which could affect your ability to drive and/or operate machinery. Patients should avoid operating hazardous machinery, including automobiles, 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 them before taking this medication.

3. How to take Periactin

Follow the administration instructions for the medication contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Adults

The recommended initial dose is 4 mg (1 tablet) three times a day; afterwards, the dose should 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 from 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 from 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 from 15 years:The recommended initial dose is 4 mg (1 tablet) three times a day; afterwards, the dose should 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 stimulated central nervous system function, convulsions, respiratory and cardiac arrest, and death, especially in children.

Gastrointestinal symptoms and other symptoms such as dry mouth, flushing, and pupil dilation may also appear.

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 forgotten doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

The frequently occurring side effects are drowsiness and tendency to sleep. Many patients who experience drowsiness at the start of treatment recover normality after 3 or 4 days of treatment.

During the period of use of ciproheptadine, the following adverse reactions have been reported, whose frequency could not be established with accuracy:

• hemolytic anemia, decreased white blood cells, decreased granulocytes, decreased platelets
• allergic edema (swelling of the face, lips, mouth, tongue, or throat), anaphylactic shock (severe allergic reaction)
• increased appetite, decreased appetite
• agitation, confusion, feeling of being 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, convulsions, 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
• dry nose, dry throat, thickening of bronchial secretions, chest tightness, wheezing (respiratory sounds), sneezing, nasal congestion
• dry mouth, stomach discomfort, nausea, vomiting, diarrhea, constipation
• jaundice (yellowish color of skin and mucous membranes), increased transaminases in blood
• allergic dermatitis, excessive sweating, urticaria, increased skin sensitivity to sunlight and ultraviolet light (photosensitivity)
• frequent urination, difficult urination, urinary retention
• early menstruation
• fatigue, chills, tiredness
• weight gain

Reporting 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 Medication Surveillance System for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Periactin

Keep this medication out of 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 thrown down the drain or into the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. Deposit the packaging and medications you no longer need in the SIGRE point of the pharmacy. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Angileptol mint flavor

Each tablet contains:

• The active ingredients:

Chlorhexidine dihydrochloride, 5 mg

Benzocaine, 4 mg

Enoxolone, 3 mg

• The other components (excipients) are: sorbitol (E420), acesulfame potassium (E950), magnesium stearate, and mint flavor

Appearance of the product and package contents

Angileptol are sucking tablets, white, round, and with the Greek letter σ on one of the faces.

They come in packages containing 15 and 30 sucking tablets.

Other presentations

Angileptol Mint-eucalyptus flavor

Angileptol Honey-lemon flavor

Marketing authorization holder

Alfasigma Spain S.L.

C/ Aribau 195, 4th floor

08021 Barcelona, Spain

Manufacturer

Pharmaloop, S.L.

Polígono Industrial Azque C/Bolivia, 15

28806 Alcalá de Henares (Madrid), Spain

or

Alfasigma, S.p.A.

Via Pontina, Km 30,400

00071 Pomezia (Rome), Italy

Date of the last revision of this leaflet:September 2021

Other sources of information

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es