MELATONIN PERRIGO 3 mg TABLETS

Introduction

Package Leaflet: Information for the User

Melatonin Perrigo 3 mg Tablets

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

Follow exactly the administration instructions of this medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 6 days.

Contents of the Package Leaflet:

1. What is Melatonin Perrigo and what is it used for
2. What you need to know before taking Melatonin Perrigo
3. How to take Melatonin Perrigo
4. Possible side effects
5. Storage of Melatonin Perrigo
6. Contents of the pack and further information

1. What is Melatonin Perrigo and what is it used for

The active substance of Melatonin Perrigo is melatonin. Melatonin is a hormone that is also produced naturally by the body.

Melatonin is used for the treatment of jet-lag in adults. Jet-lag is a disruption of the sleep-wake rhythm that can occur after crossing several time zones during air travel.

2. What you need to know before taking Melatonin Perrigo

Do not take Melatonin Perrigo

• 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 or pharmacist before taking this medicine in the following cases:

• If you are so drowsy that it could pose a risk to your safety.
• If you have a liver disease. There are no data available on the effect of Melatonin Perrigo in people with liver diseases, so the use of this medicine is not recommended in these cases.
• If you have epilepsy, the use of melatonin may increase the number of epileptic seizures.
• If you have an autoimmune disease. In patients with an autoimmune disease, rare cases of worsening symptoms have been reported after taking melatonin. Therefore, talk to your doctor if you want to take this medicine. The use of this medicine is not recommended in people with autoimmune diseases.
• If your blood sugar level is too high or if you have diabetes. If you take melatonin during a meal rich in carbohydrates (e.g., bread, potatoes, pasta, sugar), this may alter blood sugar levels. Therefore, you should not use this product in the 2-hour period before to 3 hours after a meal. Always take this product at least 3 hours after a meal if you suffer from severely altered glucose tolerance or diabetes.
• If you are a smoker. The effect of this medicine may not be as strong in people who smoke, as the components of tobacco smoke can accelerate the breakdown of melatonin in the liver.

Children and adolescents up to 18 years

Do not give this medicine to children. The use of this product has not been studied in children, and therefore, its safety and efficacy are not known.

Other medicines and Melatonin Perrigo

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine at the same time as Melatonin Perrigo.

This is particularly important if you are taking sleeping pills, sedatives (such as zolpidem, imipramine, and thioridazine), antidepressants (such as fluvoxamine), estrogens (contraceptives or hormone replacement therapy), anticoagulants, medicines to prevent epileptic seizures, anti-inflammatory drugs, and medicines for skin problems.

Taking Melatonin Perrigo with food and drinks

Do not drink alcohol before, during, or after taking melatonin.

Food can increase the concentration of melatonin in the blood. The use of melatonin in combination with carbohydrate-rich meals (e.g., bread, potatoes, pasta, sugar) may affect blood sugar regulation for several hours. You should not eat in the 2-hour period before to 2 hours after taking melatonin. If your blood sugar levels are too high or you have diabetes, then you should not eat in the 2-hour period before to 3 hours after taking melatonin.

Pregnancy and breastfeeding

You should avoid using this medicine if you are pregnant, think you may be pregnant, want to become pregnant, or are breastfeeding.

Driving and using machines

Melatonin can cause drowsiness. You should not drive or use machines if you feel drowsy. Consult your doctor if symptoms of drowsiness persist.

Melatonin Perrigo contains lactose

Each Melatonin Perrigo 3 mg tablet contains 65.3 mg of lactose monohydrate.

Consult your doctor before taking this medicine if you know you cannot tolerate certain sugars.

Melatonin Perrigo contains sodium

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

3. How to take Melatonin Perrigo

Follow exactly the administration instructions of this medicine contained in this package leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is 3 to 5 mg per day, for a period of 3 to 6 days.

The tablets should be swallowed whole with a little water. The score line is only to facilitate breaking the tablet if you find it difficult to swallow whole.

Take the tablets just before bedtime (local time) from the first day that the sleep rhythm is disrupted. It is recommended not to take the tablets before 8:00 PM or after 4:00 AM at the destination.

Also, see the section "Melatonin Perrigo with food and drinks".

If you take more Melatonin Perrigo than you should

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 taken.

Taking a daily dose higher than recommended may cause you to feel more drowsy and suffer from dizziness, headache, and nausea. No special treatment is required after an overdose.

If you forget to take Melatonin Perrigo

If you forget to take the tablet at bedtime and wake up during the night, you can take the missed dose. Do not take a double dose to make up for missed doses.

If you stop taking Melatonin Perrigo

You can stop using this medicine at any time. No harmful effects are known from stopping treatment or ending it prematurely. To date, no cases of withdrawal symptoms have been reported after stopping melatonin treatment.

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

4. Possible side effects

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

The following side effects have been reported after taking melatonin:

• Abnormal dreams.
• Abnormal behavior.
• Abnormal sensation.
• Abnormal stools.
• Asthma.
• Incontinence.
• Pallor.
• Nosebleeds.
• Vomiting.
• Abdominal pain.
• Constipation.
• Depression.
• Depressed mood.
• Disorientation.
• Diarrhea.
• Dizziness.
• Hyperactivity.
• Dizziness.
• Epilepsy.
• Lack of emotion.
• Irritability.
• Weight loss.
• Weight gain.
• Hallucinations.
• Palpitations.
• Cough.
• Headache.
• Skin irritation.
• Rash.
• Crying.
• Hyperactivity.
• Itching.
• Breathing difficulties.
• Feeling of cold.
• Low blood pressure.
• Slowness.
• Migraine.
• Nausea.
• Difficulty swallowing.
• Nightmares.
• Eye disorder.
• Ear, nose, and throat problems.
• Belching.
• Hypersensitivity.
• Excessive sweating.
• Excessive drowsiness.
• Chest pain.
• Restlessness.
• Brown-red rounded marks on the skin.
• Sleepwalking.
• Insomnia.
• Poor quality sleep.
• Increased heart rate.
• Mood changes.
• Itchy bumps on the skin.
• Increased epileptic seizures.
• Tremor.
• Changes in liver function values in the blood.
• Decreased appetite.
• Decreased visual acuity.
• Fatigue.
• Confusion.
• Stained skin.
• Feeling of heaviness in the head.

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 package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Melatonin Perrigo

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

Store below 25°C. Store in the original packaging to protect from light.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

The expiry date of the packaging once opened is 1 month.

Do not take this product if you see that the tablets are discolored or damaged.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, 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 further information

Composition of Melatonin Perrigo

The active substance is melatonin.

The other ingredients (excipients) are silicified microcrystalline cellulose (anhydrous colloidal silica and microcrystalline cellulose), lactose monohydrate, sodium carboxymethylcellulose type A, talc, and magnesium stearate.

Appearance of the product and contents of the pack

Melatonin Perrigo 3mg tablets are white to off-white, oblong, with the inscription "MELA 3" on one side and a score line on the other side.

Pack sizes:

• Carton boxes with 10, 15, 30 tablets in blisters.
• Plastic containers with 30 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Perrigo España, S.A.

Pza. Xavier Cugat, 2 Edif. D Pl. 1ª.

08174 Sant Cugat del Vallès (Barcelona)

Spain

Manufacturer

Omega Pharma Manufacturing GmbH & Co. KG

Benzstrasse 25

71083 Herrenberg,

Germany

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

Date of the last revision of this package leaflet: July 2022

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/