Prospect: information for the patient

Methylphenidate Dr. Reddys 120 mg hard-gastrorresistant capsules EFG

Methylphenidate Dr. Reddys 240 mg hard-gastrorresistant capsules EFG

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Content of the prospect

1. What is Methylphenidate Dr. Reddys and for what it is used
2. What you need to know before starting to take Methylphenidate Dr. Reddys
3. How to take Methylphenidate Dr. Reddys
4. Possible adverse effects
5. Storage of Methylphenidate Dr. Reddys
6. Contents of the package and additional information

What is Dimethyl Fumarate Dr. Reddys

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

For what Dimethyl Fumarate Dr. Reddys is used

Dimethyl fumarateis used to treat relapsing-remitting multiple sclerosis (MS) in patients 13 years 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 Dimethyl Fumarate Dr. Reddys works

This medication 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 Dr. Reddys

• If you are allergic to dimethyl fumarateor to any of the other ingredients of this medicine (listed in section 6).
• 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 make a blood test to get a white blood cell count and check that your kidneys and liver are working properly. Your doctor will make periodic blood tests 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
• gastrointestinal diseaseor intestinal disease
• severeinfection(for example pneumonia)

You may experience herpes zoster (shingles) 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 visual changes) 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 medicine 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 medicine to children under 10 years of age because there are no available data in this age group.

Other medicines and Dimethyl Fumarate Dr. Reddys

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

• medicines that containfumaric acid esters(fumarates) used to treat psoriasis;
• medicines that affect the body's immune system, including chemotherapy, immunosuppressants orother medicines used to treat MS;
• medicines 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 medicines that containlithium;
• the use of dimethyl fumarate and the administration of certain types of vaccines (attenuated vaccines) may cause an infection, and therefore should be avoided. Your doctor will inform you if you should receive other types of vaccines (inactivated vaccines).

Taking Dimethyl Fumarate Dr. Reddys with alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

The information on the effects of this medicine 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 medicine 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 machines

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

Dimethyl Fumarate Dr. Reddys contains sodium

This medicine contains less than 23 mg of sodium (1mmol) per capsule; that is, it is essentially “sodium-free”.

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

Starting dose: 120 mg twice a day.

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

Usual dose: 240 mg 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 Dr. Reddys Dimethyl Fumarate with food– it helps to reduce some of the very frequent adverse effects (listed in section 4).

If you take more Dr. Reddys Dimethyl Fumarate than you should

If you take too many capsules, inform your doctor immediately. You may experience adverse effects similar to those described in section 4.

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 Dr. Reddys Dimethyl Fumarate

Do not take a double dose to compensate for the missed doses. You can take the missed dose if at least 4 hours 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 should remain alert to any possible symptoms of PML, as described below. The risk of PML may be higher if you have previously taken a medication that has worsened your immune system function.

The symptoms of PML may be similar to those of an MS relapse. 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 that you 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 Dr. Reddy's. Also, inform your partner or caregivers about your treatment. New symptoms may arise of which you may not be aware on your own.

?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).

Facial or body flushing (flushing) is a very common side effect..However, if the flushing 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 or 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 Dr. Reddy's and call your doctor immediately

Other side effects

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

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

?Taking the medicine with foodmay help reduce the previous side effects

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

Consult your doctorabout 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
• sensation of burning
• hot flashes, 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 can 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,

for example, 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, 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 Medicinal Products 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 and on the box after CAD.

The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medicines should not be thrown down the drain or in the trash.Deposit the containers and themedicines that you no longer need at the SIGREpoint of the pharmacy.Ask your pharmacist how to dispose of the containers and the medicines that you no longer need. In this way, you will help protect the environment.

Composition of Dr. Reddys Dimethyl Fumarate

The active ingredientis dimethyl fumarate.

Dr. Reddys Dimethyl Fumarate 120 mg: each capsule contains 120 mg of dimethyl fumarate.

Dr. Reddys Dimethyl Fumarate 240 mg: each capsule contains 240 mg of dimethyl fumarate.

The other ingredientsare microcrystalline cellulose (E460), sodium croscarmellose (E468), povidone K30, talc (E553b), magnesium stearate (E1505), copolymer of methacrylic acid and methyl methacrylate (1:1) (E1205), sodium lauryl sulfate (E470a), triethyl citrate (E1505), copolymer of methacrylic acid and ethyl acrylate (1:1) dispersion at 30% (E1205), polysorbate 80 (E433), gelatin, titanium dioxide (E171), brilliant blue FCF (E133), yellow iron oxide (E172), shellac, potassium hydroxide, and black iron oxide (E172).

Appearance of the product and contents of the package

Dr. Reddys Dimethyl Fumarate 120 mg hard gastro-resistant capsules (size 1, approximately 19.3 mm) are green and white and have "RDY" printed on the cap and "429" on the body.

Each blister contains 14 or 56 capsules.

Each single-dose blister contains 14 x 1 capsules.

Dr. Reddys Dimethyl Fumarate 240 mg hard gastro-resistant capsules (size 0, approximately 21.4 mm) are green and have "RDY" printed on the cap and "430" on the body.

Each blister contains 14, 56, 112, 168, or 196 capsules.

Each single-dose blister contains 56 x 1 capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder

ReddyPharmaIberia, S.A.

AvdaJosepTarradellas, nº 38

08029 Barcelona(España)

Teléfono: 93 355 49 16

Fax: 93 355 49 61

Responsible for manufacturing

betapharm Arzneimittel GmbH,

Kobelweg 95,

86156 Augsburg

Germany

or

Pharmadox Healthcare Ltd.,

KW20A Kordin Industrial Park

Paola PLA 3000

Malta

or

Rual Laboratories SRL

313, Splaiul Unirii, Building H

1st floor, sector 3

030138 Bucuresti

Romania

or

Laboratori Fundacio Dau,

Calle Lletra C De La Zona Franca, 12-14,

Poligono Industrial De La Zona Franca De Barcelona,

Barcelona, 08040,

Spain.

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:June 2024

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/