PINEALIN 3 mg TABLETS

Introduction

Package Leaflet:information for the patient

Pinealin 3mg tablets

melatonin

Read all of this leaflet carefully before you start taking this medicine,because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.

• This medicine has been prescribed for you only, and you should not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Pinealin and what is it used for
2. What you need to know before you take Pinealin
3. How to take Pinealin
4. Possible side effects

5 Storage of Pinealin

1. Contents of the pack and other information

1. What is Pinealin and what is it used for

The active substance in Pinealin is melatonin, which belongs to a group of natural hormones produced by the body. The hormone helps regulate the body's day and night rhythm.

This medicine is used for:

• Short-term treatment of jet lag in adults. Jet lag refers to the symptoms caused by the time difference when traveling across different time zones.
• Insomnia in children and adolescents (from 6 to 17 years) with attention deficit hyperactivity disorder (ADHD), in whom sleep hygiene measures have been insufficient.

2. What you need to know before you take Pinealin

Do not take Pinealin

• if you are allergic to melatonin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take melatonin if you:

• have diabetes or glucose intolerance, as this medicine may increase blood glucose levels.
• have kidney or liver disease.
• have an autoimmune disease (when the body is "attacked" by its own immune system).
• have epilepsy, as melatonin may increase the frequency of seizures in patients with epilepsy.
• smoke. Smoking may reduce the effectiveness of melatonin. Your doctor may need to adjust your dose.
• are a woman of childbearing age. Contraceptives should be used during treatment with melatonin. However, this medicine may be affected by certain contraceptives; for more information, see the section "Other medicines and Pinealin".

It is not clear if elderly people are sensitive to melatonin.

Children and adolescents

This medicine should not be given to children under 18 years for the treatment of jet lag, as it has not been evaluated in this age group and its effects are unknown.

This medicine should not be given to children with ADHD under 6 years for the treatment of insomnia, as its safety and efficacy are unknown.

Other medicines and Pinealin

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

If melatonin is taken at the same time as the following medicines, it may affect how melatonin or the other medicine works:

• Depression (e.g., fluvoxamine, citalopram)
• Sleep disorders (e.g., zolpidem)
• Epilepsy (carbamazepine, phenytoin)
• Ulcers (cimetidine, omeprazole)
• Skin disorders (psoralens)
• Heart conditions (verapamil)
• Hypertension (e.g., nifedipine, beta-blockers)
• Bacterial infections (ciprofloxacin and norfloxacin)
• Tuberculosis (rifampicin)
• Prevention and treatment of blood clots (e.g., warfarin)
• Contraceptives containing ethinylestradiol and gestagen
• Hormone replacement therapy for menopausal problems
• Pain and inflammation (non-steroidal anti-inflammatory drugs, e.g., acetylsalicylic acid and ibuprofen)
• Caffeine

Taking Pinealin with alcohol

Do not drink alcohol while taking melatonin, as it may reduce the effect of melatonin.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, do not use this medicine.

Contraceptives for women of childbearing age and young women

Women of childbearing age and young women should use contraceptives when taking melatonin. Some contraceptives may increase melatonin levels in the body (see "Other medicines and Pinealin").

Pregnancy

This medicine is not recommended if you are pregnant. Melatonin crosses the placenta, and there is not enough information on the risk this may pose to the fetus.

Breastfeeding

This medicine is not recommended during breastfeeding. Melatonin passes into breast milk, and it cannot be ruled out that it may pose a risk to the breastfed child.

Driving and using machines

This medicine may make you feel drowsy. If this happens, do not drive or use machinery.

Pinealin contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Pinealin

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

Adults with jet lag

The standard dose is 3 mg per day for a maximum of 5 days. The dose may be gradually adjusted within the range of 0.5 to 5 mg per day to alleviate your symptoms. You should take the lowest dose that alleviates your symptoms for the shortest possible time. The maximum treatment duration is 5 days.

You should take the first dose upon arrival at your destination at the time you normally go to bed. On the following days, you should also take the dose at the time you normally go to bed. The tablets should not be taken before 8:00 pm or after 4:00 am.

Melatonin can be taken for a maximum of 16 treatment periods per year.

Insomnia in children and adolescents with ADHD

Treatment with melatonin is prescribed by your doctor because other treatable causes of sleep disorders have been ruled out and other sleep hygiene measures have been insufficient.

The recommended initial dose is 0.5 to 2 mg, taken 30 to 60 minutes before bedtime. The dose will be individually adjusted up to a maximum of 5 mg per day, regardless of age. The lowest possible dose will be administered.

Treatment should be regularly monitored by a doctor (recommended at least every 6 months) to check if it is still appropriate. Treatment should be interrupted once a year to see if it is still necessary.

Diabetes

If you or your child have diabetes or glucose intolerance, you should not consume food 2 hours before or 2 hours after taking melatonin, see Warnings and precautions.

How to take the medicine

Melatonin should be swallowed. If necessary, the tablet can be crushed and dispersed in water before ingestion.

Food should not be ingested 2 hours before or 2 hours after taking melatonin.

If you take more Pinealin than you should

If you or your child have accidentally taken too much medicine or, for example, a child has ingested the medicine by mistake, contact a doctor, hospital, or pharmacist as soon as possible.

Taking a dose higher than the recommended daily dose may make you feel drowsy, get a headache, feel dizzy, or feel nauseous.

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 medicine and the amount used.

If you forget to take Pinealin

If you forget to take a dose at bedtime and wake up during the night, you can take the missed dose but no later than 4:00 am.

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

If you stop taking Pinealin

No harmful effects are known if treatment is stopped or finished. It is not known that the use of Melatonin causes any withdrawal symptoms after treatment is finished.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

If you experience any of the following serious side effects, stop taking this medicine and consult your doctor immediately:

• Hypersensitivity reaction with symptoms such as swelling of the face, swelling of the mouth, swelling of the tongue (Frequency not known: frequency cannot be estimated from the available data),
• Chest pain (Rare side effects: may affect up to 1 in 1,000 people).

Other side effects

If you experience any of the following side effects, contact a doctor and/or seek medical advice:

Common side effects: may affect up to 1 in 10 people

• Headache.
• Drowsiness.

Uncommon side effects: may affect up to 1 in 100 people

• Irritability, nervousness, restlessness, anxiety.
• Insomnia, abnormal dreams, nightmares.
• Migraine, dizziness.
• Lethargy (fatigue) and lack of energy, restlessness associated with increased activity.
• Hypertension.
• Abdominal pain, indigestion, mouth ulcers, dry mouth, nausea.
• Changes in blood composition that can cause yellowing of the skin and eyes.
• Skin inflammation, itching, skin rash, dry skin, night sweats.
• Pain in arms and legs.
• Glucose in the urine, excess protein in the urine.
• Menopausal symptoms.
• Feeling of weakness, chest pain.
• Abnormal liver function tests.
• Weight gain.

Rare side effects: may affect up to 1 in 1,000 people

• Herpes zoster.
• Decreased number of white blood cells in the blood.
• Decreased number of platelets.
• Low levels of calcium or sodium in the blood.
• High levels of fat in the blood.
• Mood alteration, aggression, crying, stress symptoms, disorientation, early awakening, increased sexual desire, depressive mood, depression.
• Fainting, memory disorders, attention disorders, dreamy state, restless legs syndrome, poor sleep quality, sensation of "tingling".
• Visual disturbances, blurred vision, watery eyes.
• Dizziness (feeling of dizziness or "spinning"), dizziness when standing or sitting.
• Feeling heartbeats.
• Hot flashes.
• Acid reflux, gastrointestinal disorder, mouth sores, tongue ulcers, stomach upset, vomiting, abnormal intestinal sounds, gas, excessive saliva production, bad breath, abdominal discomfort, stomach disorder, stomach mucosa inflammation.
• Eczema, skin rash, inflammation of the skin of the hands, itchy rash, psoriasis, nail disorder.
• Arthritis, muscle spasms, neck pain, nocturnal cramps.
• Passing large amounts of urine, urinating at night, presence of red blood cells in the urine.
• Prolonged erection - which can be painful - without sexual stimulation, prostate inflammation.
• Fatigue, pain, thirst.
• Increased liver enzymes, abnormal blood electrolytes, and abnormal laboratory tests.

Side effects of unknown frequency: (cannot be estimated from the available data)

• Abnormal milk secretion.
• Hallucinations (e.g., seeing, feeling, or hearing things that do not exist).
• Drowsiness, sedation.
• High blood sugar.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pinealin

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 label after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage temperature. Store in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Pinealin composition

• The active substance is melatonin 3 mg.
• The other ingredients are microcrystalline cellulose (E 460), mannitol (E 421), colloidal anhydrous silica (E 551), sodium croscarmellose (E 468), and magnesium stearate (E 470b).

Appearance and packaging of the product

Pinealin 3 mg is a white or almost white, round, biconvex tablet with "3" marked on one side. The tablet size is 8 mm.

This medicine is available in plastic bottles with a safety cap or a child-resistant cap. Pack sizes are 30 or 100 tablets per bottle.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

AGB-Pharma AB

Scheeletorget 1, Medicon Village

223 81 Lund,

Sweden

Manufacturer

Legosan AB

Viagatan 16

692 35 Kumla,

Sweden

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: October 2023

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