PINEALIN 2 mg TABLETS

Introduction

Leaflet:information for the patient

Pinealin 2mg tablets

melatonin

Read the entire leaflet carefully before starting to take this medication,as it contains important information for you.

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

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

5 Storage of Pinealin

1. Package contents and additional information

1. What is Pinealin and what is it used for

The active ingredient of 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 medication 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 (6 to 17 years old) with attention deficit hyperactivity disorder (ADHD), in whom sleep hygiene measures have been insufficient.

2. What you need to know before taking Pinealin

Do not take Pinealin

• if you are allergic to melatonin or any of the other components of this medication (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 medication 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 the dose.
• are a woman of childbearing age. Contraceptives should be used during treatment with melatonin. However, this medication may be affected by certain contraceptives; for more information, see "Other medications and Pinealin".

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

Children and adolescents

This medication should not be administered to minors under 18 years old to treat jet lag, as it has not been evaluated in this age group and its effects are unknown.

Do not administer this medication to children with ADHD under 6 years old to treat insomnia, as its safety and efficacy are unknown.

Other medications and Pinealin

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

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

• Depression (e.g., fluvoxamine, citalopram)
• Sleep disorders (e.g., zolpidem)
• Epilepsy (carbamazepine, phenytoin)
• Ulcers (cimetidine, omeprazole)
• Skin disorders (psoralens)
• Cardiovascular diseases (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 menopause 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 plan to become pregnant, you should not use this medication.

Contraceptives for fertile women and young women

Fertile women and young women should use contraceptives when taking melatonin. Some contraceptives may increase melatonin levels in the body (see "Other medications and Pinealin").

Pregnancy

This medication is not recommended if you are pregnant. Melatonin crosses the placenta, and there is not enough information about the risk it may pose to the fetus.

Breastfeeding

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

Pinealin contains sodium

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

3. How to take Pinealin

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If 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 subsequent 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 may 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 medication

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 an excessive amount of medication or, for example, a child has ingested the medication by mistake, contact a doctor, hospital, or pharmacist as soon as possible.

Taking a quantity higher than the recommended daily dose may make you feel drowsy, cause headaches, dizziness, and nausea.

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 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 interrupt treatment with Pinealin

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

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

4. Possible side effects

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

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

• Hypersensitivity reaction with symptoms such as facial swelling, mouth swelling, tongue swelling (Frequency not known: frequency cannot be estimated from 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, 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.
• Reduced number of white blood cells in the blood.
• Reduced number of platelets.
• Low calcium or sodium levels in the blood.
• High fat levels in the blood.
• Mood changes, aggression, crying, stress symptoms, disorientation, premature awakening, increased libido, depressive mood, depression.
• Fainting, memory disorders, attention disorders, dreamy state, restless legs syndrome, poor sleep quality, feeling 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, rash, skin inflammation on the hands, itchy rash, psoriasis, nail disorder.
• Arthritis, muscle spasms, neck pain, nocturnal cramps.
• Urinating large amounts, 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 available data)

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Pinealin

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

Do not use this medication after the expiration date stated on the label after EXP. The expiration date is the last day of the month indicated.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Pinealin composition

• The active ingredient is melatonin 2 mg.
• The other components are microcrystalline cellulose (E 460), mannitol (E 421), anhydrous colloidal silica (E 551), sodium croscarmellose (E 468), and magnesium stearate (E 470b).

Product appearance and package contents

Pinealin 2 mg is a white or almost white, round, biconvex tablet, with "2" marked on one side. The tablet size is 8 mm.

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

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