Patient Information Leaflet

Methylphenidate Tevagen 120mg Hard Gastrorresistant Capsules EFG

Methylphenidate Tevagen 240mg Hard Gastrorresistant Capsules EFG

methylphenidate

Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section4.

1.What is Methylphenidate Tevagen and what it is used for

2.What you need to know before you start taking Methylphenidate Tevagen

3.How to take Methylphenidate Tevagen

4.Possible side effects

5.Storage of Methylphenidate Tevagen

6.Contents of the pack and additional information

What is Tevagen Dimethyl Fumarate

Tevagen Dimethyl Fumarate is a medication that containsdimethyl fumarateas the active ingredient.

What is Tevagen Dimethyl Fumarate used for

Tevagen Dimethyl Fumarate is used to treat relapsing-remitting multiple sclerosis (MS) in patients 13years of age and older..

MS is a long-term disease that affects the central nervous system (CNS), which includes the brain and spinal cord. Relapsing-remitting MS is characterized by repeated attacks (exacerbations) of neurological symptoms. Symptoms vary from patient to patient but often include: difficulties walking, balance problems, and visual problems (e.g., blurred vision or double vision). These symptoms may disappear completely when the exacerbation ends, but some problems may persist.

How Tevagen Dimethyl Fumarate works

Tevagen Dimethyl Fumarate appears to act by preventing the body's defense system from damaging the brain and spinal cord. This may also help to delay future deterioration of MS.

Do not take Dimethyl Fumarate Tevagen

• If you are allergic to dimethyl fumarateor to any of the other components of this medication (listed in section6).
• If you suspect you have a rare brain infection called progressive multifocal leukoencephalopathy (PML) or if PML has been confirmed.

Warnings and precautions

Dimethyl fumarate may affect thenumber of white blood cells, thekidneysand theliver. Before starting dimethyl fumarate, your doctor will perform a blood test to obtain a white blood cell count and check that your kidneys and liver are functioning correctly. Your doctor will perform blood tests periodically during treatment. If you experience a decrease in the number of white blood cells during treatment, your doctor may consider additional tests or interrupt your treatment.

Consult your doctorbefore starting to take dimethyl fumarate if you have:

• severerenal disease
• severehepatic disease
• a disease of thestomachor theintestine
• a severeinfection(for example, pneumonia)

Herpes zoster (shingles) may occur during treatment with dimethyl fumarate. In some cases, serious complications have occurred.You must inform your doctor immediatelyif you suspect you have any of the symptoms of shingles.

If you think your MS is worsening (e.g., weakness or changes in vision) or notice the appearance of any new symptoms, speak directly with your doctor, as they may be symptoms of a rare brain infection called PML. PML is a serious disease that can cause death or severe disability.

A rare but serious kidney disorder called Fanconi syndrome has been reported with a medication that contains dimethyl fumarate in combination with other fumaric acid esters, and that is used to treat psoriasis (a skin disease). If you notice that you are urinating more, are more thirsty and drink more than usual, your muscles seem weaker, you break a bone or simply have pain and discomfort, inform your doctor as soon as possible so that this can be investigated further.

Children and adolescents

Do not give this medication to children under 10 years of age because there are no available data in this age group.

Other medications and Dimethyl Fumarate Tevagen

Inform your doctor or pharmacistif you are taking, have taken recently or may need to take any other medication, in particular:

• medications that containfumaric acid esters(fumarates) used to treat psoriasis
• medications that affect the body's immune system,including chemotherapy, immunosuppressants orother medications used to treat MS
• medications that affect the kidneys, includingsomeantibiotics(used to treat infections),diuretics(tablets that increase urine elimination),certain types of analgesics(such as ibuprofen or other anti-inflammatory medications, and over-the-counter medications) and medications that containlithium
• The use of this medication and the administration of certain types ofvaccines(attenuated vaccines) may cause an infection and, therefore, should be avoided. Your doctor will indicate if you should receive other types of vaccines (inactivated vaccines).

Dimethyl Fumarate Tevagen and alcohol

After taking dimethyl fumarate, avoid consuming a small amount (more than 50ml) of strong alcoholic beverages (with a volume of alcohol of more than 30%, such as spirits) during the first hour because alcohol may interact with this medication. It may cause inflammation of the stomach (gastritis), especially in people with a tendency to suffer from this condition.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Pregnancy

The information on the effects of this medication on the fetus if used during pregnancy is limited. Do not use dimethyl fumarate during pregnancy unless you have discussed this with your doctor and this medication is clearly necessary in your case.

Breastfeeding

It is unknown whether the active ingredient of dimethyl fumarate passes into breast milk. Your doctor will inform you if you should stop breastfeeding or if you should stop taking dimethyl fumarate. This decision involves weighing the benefits of breastfeeding for your child and the benefits of treatment for you.

Driving and operating machinery

Dimethyl fumarate is not expected to affect your ability to drive and operate machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor again.

Starting Dose

120mg twice a day.

Take this starting dose for the first 7days, then take the usual dose.

Usual Dose

240mg twice a day.

Dimethyl fumarate is taken orally.

The capsules should be swallowed whole, with some water. Do not break, crush, dissolve, or chew or suck on the capsules because some adverse effects may increase.

Take Dimethyl Fumarate Tevagen with food– helps to reduce some very frequent adverse effects (including in section4).

If you take more Dimethyl Fumarate Tevagen than you should

If you take too many capsules,inform your doctor immediately. You may experience adverse effects similar to those described in section4.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

If you forgot to take Dimethyl Fumarate Tevagen

Do not take a double doseto compensate for the missed doses.

You can take the missed dose if at least 4hours have passed between doses. Otherwise, wait until the next scheduled dose.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects

Methylphenidate hydrochloride may decrease your lymphocyte count (a type of white blood cell). A low white blood cell count can increase the risk of infection, including a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML can cause death or severe disability. PML has occurred after 1 to 5 years of treatment, so your doctor must continue to monitor your white blood cells throughout treatment and you must remain alert to any possible symptoms of PML, as described below. The risk of PML may be higher if you have previously taken a medicine that has worsened your immune system function.

The symptoms of PML may be similar to those of MS. Symptoms may include new or worsening weakness on one side of the body; clumsiness; changes in vision, thinking, or memory; or confusion or changes in personality, or difficulty speaking and communicating that may persist for more than several days. Therefore, it is very important to speak with your doctor as soon as possible if you think your MS is worsening or if you notice any new symptoms while taking methylphenidate hydrochloride. Also, inform your partner or caregivers about your treatment. New symptoms may arise of which you may not be aware.

• Call your doctor immediately if you experience any of these symptoms

Severe allergic reactions

The frequency of severe allergic reactions cannot be estimated from the available data (unknown frequency).

Redness of the face or body (erythema) is a very common side effect. However, if the redness is accompanied by a red rash or hives and you experience any of the following symptoms:

• swelling of the face, lips, mouth, or tongue (angioedema)
• whistling when breathing, difficulty breathing, or shortness of breath (dyspnea, hypoxia)
• dizziness or loss of consciousness (hypotension)

it may then constitute a severe allergic reaction (anaphylaxis).

• Stop taking methylphenidate hydrochloride Tevagen and call your doctor immediately

Other side effects

Very common(may affect more than 1 in 10 people)

• redness of the face or body, feeling of heat, heat, burning sensation, or itching (erythema)
• loose stools (diarrhea)
• nausea or vomiting
• stomach pain or cramps

• Taking the medicine with food may help reduce the above side effects

While taking methylphenidate hydrochloride, it is common for urine tests to show ketones, substances that are naturally produced in the body.

Consult your doctor about how to treat these side effects. Your doctor may reduce your dose. Do not reduce your dose unless your doctor tells you to.

Common(may affect up to 1 in 10 people)

• inflammation of the intestinal mucosa (gastroenteritis)
• vomiting
• indigestion (dyspepsia)
• inflammation of the stomach mucosa (gastritis)
• gastrointestinal disorders
• burning sensation
• flushes, feeling of heat
• skin itching (pruritus)
• exanthema
• rosy or reddish patches accompanied by itching on the skin (erythema)
• hair loss (alopecia)

Side effects that may appear in blood or urine tests

• low white blood cell count (lymphopenia, leukopenia) in blood. A decrease in white blood cells may make the body less able to fight infections. If you have a severe infection (such as pneumonia) inform your doctor immediately.
• protein (albumin) in urine
• increase in liver enzymes (ALT, AST) in blood

Rare(may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity)
• reduction of platelets in the blood

Unknown frequency(cannot be estimated from the available data)

• inflammation of the liver and increase in liver enzymes (ALT or AST simultaneously with bilirubin)
• herpes zoster (shingles) with symptoms such as blisters, burning, itching, or pain on the skin, usually on one side of the upper body or face, and other symptoms, such as fever and weakness in the early stages of the infection, followed by numbness, itching, or red patches with intense pain
• nasal secretion (rhinorrhea)

Children (13 years of age and older) and adolescents

The side effects described above also apply to children and adolescents.

Some side effects were reported more frequently in children and adolescents than in adults, p.eg, headache, stomach pain or cramps, vomiting, sore throat, cough, and painful menstruation.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the blister pack, bottle, and box after CAD or 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 drains or in the trash.Deposit containers and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of containers and medications you no longer need. This will help protect the environment.

Composition of Tevagen Dimethyl Fumarate

The active ingredient is dimethyl fumarate.

Tevagen Dimethyl Fumarate 120mg hard gastro-resistant capsules EFG

Each hard gastro-resistant capsule contains 120mg of dimethyl fumarate.

Tevagen Dimethyl Fumarate 240mg hard gastro-resistant capsules EFG

Each hard gastro-resistant capsule contains 240mg of dimethyl fumarate.

The other components are:

• Capule content: microcrystalline cellulose, crospovidone, talc, povidone, anhydrous colloidal silica, magnesium stearate, triethyl citrate, copolymer of methacrylic acid and ethyl acrylate (1:1), hypromellose, titanium dioxide (E171), triacetin.
• Capule coating: gelatin, titanium dioxide (E171), brilliant blue FCF-FD&C Blue 1 (E 133), yellow iron oxide (E172).
• Capule printing: shellac, potassium hydroxide, propylene glycol (E1520), black iron oxide (E172), concentrated ammonia solution.

Appearance of the product and contents of the package

Tevagen Dimethyl Fumarate 120mg hard gastro-resistant capsules EFG (hard gastro-resistant capsules): capsules with a white body and a green cap, with a size of 21.4 mm in length, with the imprint “DMF 120” in black ink on the body containing white or off-white mini tablets.

Tevagen Dimethyl Fumarate 240mg hard gastro-resistant capsules EFG (hard gastro-resistant capsules): capsules with a green body and cap, with a size of 23.2 mm in length, with the imprint “DMF 240” in black ink on the body containing white or off-white mini tablets.

HDPE bottle with a PP/HDPE stopper and silica gel desiccant containing 100 hard gastro-resistant capsules.

Do not swallow the desiccant.

OPA/Alu/PVC//Alu or single-dose blister packs of OPA/Alu/PVC//Alu

Tevagen Dimethyl Fumarate 120mg hard gastro-resistant capsules EFG:

Package sizes:

14capsules(blister packs)

14 x 1capsules(perforated single-dose blister packs)

100 capsules (bottle)

Only some package sizes may be marketed.

Tevagen Dimethyl Fumarate 240mg hard gastro-resistant capsules EFG

Package sizes:

56capsules(blister packs)

56 x 1capsules(perforated single-dose blister packs)

168capsules(blister packs)

168 x 1capsules(perforated single-dose blister packs)

100 capsules (bottle)

196capsules(blister packs)

196 x 1capsules(perforated single-dose blister packs)

Only some package sizes may be marketed.

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor

Alcobendas (Madrid), 28108, Spain.

Responsible for manufacturing

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola PLA 3000

Malta

Adalvo Ltd.

Malta Life Sciences Park,

Building 1, Level 4, Sir Temi Zammit Buildings,

San Gwann SGN 3000

Malta

KeVaRo GROUP EOOD

9 Tzaritza Elenora Str. Office 23

Sofia 1618

Bulgaria

Last review date of this leaflet:July 2024

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/89165/P_89165.html

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