Modafinil Tarbis 100 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Modafinil Tarbis 100 mg tablets EFG

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor, pharmacist or nurse, even if the effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Modafinil Tarbis is and what it is used for
2. What you need to know before taking Modafinil Tarbis
3. How to take Modafinil Tarbis
4. Possible adverse effects
5. How to store Modafinil Tarbis
6. Contents of the pack and other information

1. What Modafinilo Tarbis is and what it is used for

The active substance in the tablets is modafinil.

Modafinil can be used by adults suffering from narcolepsy to help them stay awake.

Narcolepsy is a condition that causes excessive daytime sleepiness and a tendency to fall asleep suddenly in inappropriate situations (sleep attacks). Modafinil can improve narcolepsy and reduce the likelihood of experiencing sleep attacks, although there may also be other ways to improve your condition, and your doctor will inform you about them.

2. What you need to know before taking Modafinil Tarbis

Do not take Modafinil Tarbis

• if you are allergic to modafinil or to any of the other ingredients of this medicine (listed in section 6).
• if you suffer from irregular heartbeat.
• if you have moderate to severe, uncontrolled high blood pressure (hypertension).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting Modafinil Tarbis.

-if you have heart problems or high blood pressure. Your doctor will carry out regular checks while you are being treated with medicines containing modafinil.

• if you have ever had depression, low mood, anxiety, psychosis (loss of contact with reality), mania (hyperexcitability or elevated mood), or bipolar disorder, as medicines containing modafinil may worsen your condition.
• if you have a kidney or liver disease (as you may need a lower dose).
• if you have previously had problems with alcohol or drugs.

Children and adolescents

Children under 18 years of age must not take this medicine.

Other matters to discuss with your doctor or pharmacist

Some people have reported suicidal thoughts or aggressive behaviour while taking this medicine. Contact your doctor immediately if you notice that you feel depressed, feel aggression or hostility towards others, or have suicidal thoughts or other changes in behaviour (see section 4). You may ask a family member or close friend to help monitor you for signs of depression or other changes in behaviour.

This medicine may make you feel that you need it (dependence) after long-term use. If you need to take it for a prolonged period, your doctor will periodically review whether it remains the appropriate medicine for you.

Taking Modafinil Tarbis with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Medicines containing modafinil and other medicines can affect each other, and your doctor may need to adjust the doses you are taking. It is especially important if you are taking any of the following medicines together with medicines containing modafinil:

• Hormonal contraceptives (including contraceptive pills, implants, intrauterine devices (IUDs), and patches). You should consider alternative contraceptive methods while taking medicines containing modafinil and for at least two months after stopping treatment, as medicines containing modafinil reduce their effectiveness.
• Omeprazole (for reflux acid, indigestion, or ulcers).
• Antiviral medicines for the treatment of HIV infection (protease inhibitors, e.g. indinavir or ritonavir).
• Cyclosporine (used to prevent rejection of transplanted organs or for arthritis or psoriasis).
• Medicines for epilepsy (e.g. carbamazepine, phenobarbital, or phenytoin).
• Medicines for depression (e.g. amitriptiline, citalopram, or fluoxetine) or anxiety (e.g. diazepam).
• Medicines to thin the blood (e.g. warfarin). Your doctor will monitor your clotting time during treatment.
• Calcium channel blockers or beta-blockers for high blood pressure or heart problems (e.g. amlodipine, verapamil, or propranolol).
• Statins, medicines to reduce cholesterol (e.g. atorvastatin or simvastatin).

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, you must not take modafinil.

Modafinil is suspected of causing congenital malformations if taken during pregnancy.

Consult your doctor about suitable contraceptive methods while being treated with medicines containing modafinil (and for two months after stopping treatment) or if you have any other questions.

Driving and using machines

Medicines containing modafinil may cause blurred vision or dizziness in 1 out of every 10 patients. If you experience any of these effects or still feel sleepy while taking this medicine, avoid driving or operating machinery.

Important information about some of the ingredients of Modafinil Tarbis

Use in athletes: this medicine contains modafinil, which may result in a positive doping test.

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Modafinil Tarbis

Always follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is:

Adults

The usual dose is 200 mg per day. It can be taken once daily (in the morning) or divided into two doses per day (100 mg in the morning and 100 mg at midday).

In certain cases, your doctor may decide to increase your daily dose up to 400 mg.

Elderly patients (aged over 65 years)

The usual dose is 100 mg per day.

Your doctor will only increase the daily dose (up to a maximum of 400 mg per day) if you do not have liver or kidney disorders.

Adults with severe liver or kidney disorders

The usual dose is 100 mg per day.

Your doctor will periodically review your treatment to ensure it remains appropriate for you.

If you take more Modafinil Tarbis than you should

If you have taken too many tablets, you may feel unwell, restless, disoriented, confused, or overexcited. You may also experience difficulty sleeping, diarrhoea, hallucinations (sensations that are not real), chest pain, a change in your heart rate, or an increase in your blood pressure.

Contact the emergency department of the nearest hospital or consult your doctor or pharmacist immediately. Take this leaflet and any remaining tablets with you. You may also call the Toxicology Information Service at telephone number 915620420, stating the name of the medicine and the amount taken.

If you forget to take Modafinil Tarbis

If you forget to take your medicine, take the next dose at the usual time.

Do not take a double dose to make up for forgotten doses.

If you stop taking Modafinil Tarbis

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Stop taking this medicine and contact your doctor immediately if:

• You experience sudden wheezing, difficulty breathing, or develop swelling of the face, mouth, or throat.

• You develop a skin rash or itching (especially if it affects the entire body). Serious skin rashes may cause blisters or peeling of the skin, sores in the mouth, eyes, nose, or genitals. You may also develop an increase in body temperature (fever) and have abnormal results in blood tests.

• You notice any changes in your mental health and well-being. These signs may include:

  • mood or thought changes,
  • aggression or hostility,
  • forgetfulness or confusion,
  • feeling extremely happy,
  • hyperexcitability or hyperactivity,
  • anxiety or nervousness,
  • depression, suicidal thoughts or behaviour,
  • agitation and/or psychosis (loss of contact with reality, which may include delusional ideas or sensations that are not real), feelings of isolation or personality disorder.

Other side effects include the following:

Very common side effects (may affect more than 1 in 10 patients):

• Headache

Common side effects (may affect up to 1 in 10 patients):

• Dizziness
• Drowsiness, extreme tiredness or difficulty falling asleep (insomnia)
• Awareness of heartbeats, which may be faster than normal
• Chest pain
• Flushing
• Dry mouth
• Loss of appetite, discomfort, stomach pain, indigestion, diarrhoea or constipation
• Weakness
• Numbness or tingling in hands or feet
• Blurred vision
• Abnormal blood test results showing liver function (increase in liver enzymes)

• Irritability

Uncommon side effects (may affect up to 1 in 100 patients):

• Back pain, neck pain, muscle pain, muscle weakness, leg cramps, joint pain, spasms or tremors
• Dizziness (sensation of spinning)
• Difficulty moving muscles smoothly or other movement difficulties, muscle tension, coordination problems
• Hay fever-like symptoms including runny or itchy nose, watery eyes
• Increased cough, asthma or shortness of breath
• Skin rash, acne or skin itching
• Sweating
• Changes in blood pressure (increase or decrease), changes in heart tracing (ECG), and irregular or unusually slow heartbeats
• Difficulty swallowing, tongue swelling or mouth sores
• Excess gas, reflux (regurgitation of stomach fluid), increased appetite, weight changes, thirst or taste disturbances
• Nausea
• Migraine
• Speech disorders
• Diabetes with increased blood sugar
• Increased blood cholesterol
• Swelling of hands and feet
• Sleep disturbances or abnormal dreams
• Loss of sexual appetite
• Nosebleeds, sore throat or nasal passage inflammation (sinusitis)
• Abnormal vision or dry eyes
• Abnormal urine or increased frequency of urination
• Menstrual disorders

• Abnormal blood test results showing changes in white blood cells.

• Restlessness with increased body movements

Reporting of adverse effects:

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the national reporting system included in Annex V*. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Modafinil Tarbis

Keep out of the sight and reach of children.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE point in your pharmacy. Ask your pharmacist how to properly discard medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Modafinil Tarbis 100 mg

Each tablet contains 100 mg of modafinil as the active substance. The other components are monohydrate lactose, pregelatinized corn starch, microcrystalline cellulose, sodium croscarmellose, povidone K 29/32, talc and magnesium stearate.

Nature of the product and contents of the pack

White, circular, biconvex tablet.

The tablets are presented in blisters containing 20, 30, 50, 60, 90 or 100 tablets. Only certain pack sizes may be commercially available.

Marketing Authorization Holder

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Manufacturer

Lacer, S.A.

c/Boters, 5

08290 Cerdanyola del Vallès, Barcelona

Spain

This leaflet was approved in: July 2019

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