MELATONIN PERRIGO 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Melatonin Perrigo 5 mg Tablets

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

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

• Keep this package leaflet, as 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 they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 6 days.

Contents of the Package Leaflet:

1. What Melatonin Perrigo is and what it is 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. Package Contents and Additional Information

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

The active ingredient of Melatonin Perrigo is melatonin. Melatonin is a hormone 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

Warnings and Precautions

Consult your doctor or pharmacist before starting to take this medication 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 available data on the effect of Melatonin Perrigo in people with liver diseases, so the use of this medication 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 medication. The use of this medication 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 your blood sugar levels. Therefore, you should not use this product within 2 hours before or 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 medication 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 administer this medication to children. The use of this product has not been studied in children, and therefore, its safety and efficacy are not known.

Other Medications and Melatonin Perrigo

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication concomitantly with 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, medications to prevent epileptic seizures, anti-inflammatory medications, and medications 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 the regulation of your blood sugar level for several hours. You should not eat within 2 hours before or 2 hours after taking melatonin. If your blood sugar levels are too high or you have diabetes, then you should not eat within 2 hours before or 3 hours after taking melatonin.

Pregnancy and Breastfeeding

You should avoid using this medication 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 5 mg tablet contains 63.3 mg of lactose monohydrate.

Contact your doctor before taking this medication if you know you cannot tolerate certain sugars.

Melatonin Perrigo contains Sodium

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

3. How to take Melatonin Perrigo

Follow the administration instructions for this medication exactly as contained in this package leaflet or as indicated by your doctor or pharmacist. In case of 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, preferably with a little water. The score line is only for breaking the tablet if you find it difficult to swallow it whole.

Take the tablets just before bedtime (local time) starting from the first day your 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 medication and the amount ingested.

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 medication at any time. No harmful effects are known from stopping the treatment or terminating it early. To date, no cases of withdrawal symptoms have been reported after using melatonin due to treatment discontinuation.

If you have any further 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 will experience them.

The following side effects have been reported after using melatonin:

• Abnormal dreams.
• Abnormal behavior.
• Abnormal sensation.
• Abnormal stools.
• Asthma.
• Incontinence.
• Pallor.
• Nosebleeds.
• Vomiting.
• Abdominal pain.
• Constipation.
• Depression.
• Depressive mood (gloomy).
• Disorientation.
• Diarrhea.
• Dizziness.
• Hyperactive behavior.
• Dizziness.
• Epilepsy.
• Lack of emotion.
• Irritability (excitability).
• 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 clearly delineated on the skin.
• Sleepwalking.
• Insomnia.
• Poor sleep quality.
• Increased heart rate.
• Mood changes.
• Itchy bumps (prurigo).
• 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 Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaRAM.es.

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

5. Storage of Melatonin Perrigo

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

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

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

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

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

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Melatonin Perrigo

The active ingredient 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 Package Contents

Melatonin Perrigo 5 mg tablets are white to off-white, round, with the inscription "MELA 5" on one side and a score line on the other side.

Package sizes:

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

Not all package 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 medication 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 medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/