Venlafaxine prolonged-release Sandoz 75 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Venlafaxine Retard Sandoz 75 mg prolonged-release hard capsules EFG

Venlafaxine Retard Sandoz 150 mg prolonged-release hard capsules EFG

Venlafaxine Retard Sandoz 225 mg prolonged-release hard capsules EFG

venlafaxine

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

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

Package leaflet contents:

1. What Venlafaxine Retard Sandoz is and what it is used for

2. What you need to know before taking Venlafaxine Retard Sandoz

3. How to take Venlafaxine Retard Sandoz

4. Possible side effects

5. How to store Venlafaxine Retard Sandoz

6. Pack contents and additional information

1. What Venlafaxine Retard Sandoz is and what it is used for

Venlafaxine Retard Sandoz contains the active substance venlafaxine.

Venlafaxine Retard Sandoz is an antidepressant that belongs to a group of medicines called serotonin and noradrenaline reuptake inhibitors (SNRIs). This group of medicines is used to treat depression and other conditions such as anxiety disorders. The way antidepressants work is not fully understood, but they may help increase levels of serotonin and noradrenaline in the brain.

Venlafaxine Retard Sandoz is a treatment for adults with depression. It is also a treatment for adults with the following anxiety disorders: generalized anxiety disorder, social anxiety disorder (fear or avoidance of social situations), panic disorder (panic attacks). Properly treating depressive and anxiety disorders is important to help you feel better. If left untreated, your condition may not go away or may worsen and become more difficult to treat.

2. What you need to know before starting to take Venlafaxine Retard Sandoz

Do not take Venlafaxine Retard Sandoz

• If you are allergic to venlafaxine or to any of the other ingredients of this medicine (listed in section 6).
• If you are also taking, or have taken within the last 14 days, any medicine known as an irreversible monoamine oxidase inhibitor (MAOI) used to treat depression or Parkinson's disease. Taking an irreversible MAOI together with venlafaxine may cause serious, and potentially life-threatening, adverse effects. In addition, you must wait at least 7 days after stopping venlafaxine before starting any MAOI (see also section “Other medicines and Venlafaxine Retard Sandoz” and the information in that section regarding “Serotonin Syndrome”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Venlafaxine Retard Sandoz:

• if you are taking other medicines that, when taken together with venlafaxine, could increase the risk of developing serotonin syndrome (see section “Other medicines and Venlafaxine Retard Sandoz”),
• if you have eye problems, such as certain types of glaucoma (increased pressure in the eye),
• if you have a history of high blood pressure,
• if you have a history of heart problems,
• if you have been told that your heart rhythm is abnormal,
• if you have a history of seizures (fits),
• if you have a history of low sodium levels in the blood (hyponatremia),
• if you tend to bruise easily or have a tendency to bleed (history of bleeding disorders), or if you are taking other medicines that may increase the risk of bleeding, e.g., warfarin (used to prevent blood clots), or if you are pregnant (see “Pregnancy”),
• if you have a history of, or if a member of your family has had, mania or bipolar disorder (feeling over-excited or euphoric),
• if you have a history of aggressive behavior.

Venlafaxine may cause a feeling of restlessness or an inability to sit or stand still during the first weeks of treatment. You should consult your doctor if this happens.

Do not drink alcohol during treatment with venlafaxine, as it may cause extreme drowsiness and unconsciousness. Taking venlafaxine together with certain medicines and/or alcohol may worsen symptoms of depression and other conditions, such as anxiety disorders.

Suicidal thoughts and worsening of depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you may sometimes experience thoughts of harming yourself or suicide. These thoughts may increase when you first start taking antidepressants, as all these medicines take time to work—usually about two weeks, but sometimes longer. These thoughts may also occur when your dose is reduced or during discontinuation of treatment with Venlafaxine Retard Sandoz.

This is more likely to happen if:

• you have previously had thoughts of suicide or of harming yourself,
• you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in young adults (under 25 years of age) with psychiatric disorders treated with antidepressants.

If at any time you experience thoughts of harming yourself or of suicide, contact your doctor immediately or go to a hospital.

You may find it helpful to inform a close family member or friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You may also ask them to tell you if they think your depression or anxiety is getting worse, or if they are concerned about changes in your behaviour.

Dry mouth

Dry mouth has been reported in 10% of patients treated with venlafaxine. This may increase the risk of tooth decay (caries). Therefore, you should pay careful attention to your dental hygiene.

Diabetes

Your blood glucose levels may be altered by venlafaxine. Therefore, the doses of your diabetes medications may need to be adjusted.

Sexual problems

Some medicines in the class to which venlafaxine belongs (called SSRIs/SNRIs) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuation of treatment.

Children and adolescents

Venlafaxine should normally not be used in the treatment of children and adolescents under 18 years of age. In addition, you should be aware that in patients under 18 years of age, there is an increased risk of adverse effects such as suicidal behaviour, suicidal ideation, and hostility (predominantly aggression, confrontational behaviour, and irritability) when taking this type of medication. Nevertheless, your doctor may prescribe this medicine to patients under 18 years of age if they decide it is in the patient's best interest. If your doctor has prescribed this medicine to a patient under 18 years of age and you wish to discuss this decision, please consult your doctor again. You must inform your doctor if any of the symptoms listed above develop or worsen while these patients under 18 years of age are taking venlafaxine. Furthermore, the long-term safety regarding growth, maturation, and cognitive and behavioural development has not been established.

Other medicines and Venlafaxine Retard Sandoz

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Your doctor must decide whether you can take Venlafaxine Retard Sandoz with other medicines.

Do not start or stop taking any medicine, including those available without a prescription, natural remedies, or herbal products, without first checking with your doctor or pharmacist.

• Monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson’s disease must not be taken with Venlafaxine Retard Sandoz. Tell your doctor if you have taken any of these medicines within the last 14 days. (MAOIs: see section “What you need to know before taking Venlafaxine Retard Sandoz”).
• Serotonin syndrome:

A potentially life-threatening condition, or reactions resembling Neuroleptic Malignant Syndrome (NMS) (see section “Possible Side Effects”), may occur during treatment with venlafaxine, particularly when taken with other medicines. Examples of such medicines include:

• triptans (used for migraine),
• other medicines for treating depression, for example, SNRIs, SSRIs, tricyclic antidepressants, or medicines containing lithium,
• medicines containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity),
• medicines containing the antibiotic linezolid (used to treat infections),
• medicines containing moclobemide, an MAOI (used to treat depression),
• medicines containing sibutramine (used for weight loss),
• medicines containing opioids (e.g., buprenorphine, tramadol, fentanyl, tapentadol, meperidine, or pentazocine) used to treat severe pain,
• medicines containing dextromethorphan (used to treat cough),
• medicines containing methadone (used for opioid addiction treatment or for treating severe pain),
• medicines containing methylene blue (used to treat elevated levels of methemoglobin in blood),
• products containing St. John’s wort (also known as “Hypericum perforatum”, a natural or herbal remedy used to treat mild depression),
• products containing tryptophan (used for conditions such as sleep and depression),
• antipsychotics (used to treat a disorder with symptoms such as hearing, seeing, or feeling things that are not there, false beliefs, unusual suspiciousness, unclear thinking, and tendency to withdraw).

Signs and symptoms of serotonin syndrome may include a combination of the following: restlessness, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, hyperactive reflexes, diarrhoea, coma, nausea, vomiting.

In its most severe form, serotonin syndrome may resemble neuroleptic malignant syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, and increased muscle enzymes (determined by a blood test).

Contact your doctor immediately or go to the nearest hospital emergency department if you think you are experiencing serotonin syndrome.

Inform your doctor if you are taking medicines that may affect your heart rhythm.

Examples of such medicines include:

• antiarrhythmics such as quinidine, amiodarone, sotalol, or dofetilide (used to treat irregular heart rhythm),
• antipsychotics such as thioridazine (see also serotonin syndrome above),
• antibiotics such as erythromycin or moxifloxacin (used to treat bacterial infections),
• antihistamines (used to treat allergy).

The following medicines may also interact with Venlafaxine Retard Sandoz and should be used with caution. It is especially important to inform your doctor or pharmacist if you are taking medicines containing:

• ketoconazole (an antifungal medicine),
• haloperidol or risperidone (used to treat psychiatric conditions),
• metoprolol (a beta-blocker used to treat high blood pressure and heart problems).

Taking Venlafaxine Retard Sandoz with food, drinks, and alcohol

Venlafaxine Retard Sandoz should be taken with food (see section 3, “How to take Venlafaxine Retard Sandoz”).

Do not drink alcohol during treatment with venlafaxine. Taking it together with alcohol may cause extreme drowsiness and unconsciousness, and may worsen symptoms of depression and other conditions, such as anxiety disorders.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. You should only take Venlafaxine Retard Sandoz after discussing with your doctor the potential benefits and possible risks to the unborn child.

Ensure that your midwife and/or doctor knows that you are taking Venlafaxine Retard Sandoz. When taken during pregnancy, similar medicines (SSRIs) may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and appear blue. These symptoms usually begin within the first 24 hours after the baby's birth. If this occurs in your baby, contact your midwife and/or doctor immediately.

If you take this medicine during pregnancy, in addition to breathing problems, another symptom your baby may have at birth is feeding difficulties. If your baby has these symptoms at birth and you are concerned, contact your doctor and/or midwife, who can advise you.

If you take venlafaxine in the late stages of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking venlafaxine so they can advise you appropriately.

Venlafaxine Retard Sandoz passes into breast milk. There is a risk of effects on the baby. Therefore, discuss this with your doctor, who will decide whether you should discontinue breastfeeding or discontinue treatment with this medicine.

Driving and use of machines

Do not drive or operate tools or machinery until you know how this medicine affects you.

Venlafaxine Retard Sandoz 150 mg and 225 mg contains sodium and azoic dyes

This medicine contains less than 1 mmol (23 mg) of sodium per prolonged-release hard capsule; i.e., essentially "sodium-free".

150 mg prolonged-release hard capsules:

This medicine may cause allergic-type reactions as it contains sunset yellow FCF (E 110) and allura red AC (E 129).

225 mg prolonged-release hard capsules:

This medicine may cause allergic-type reactions as it contains carmoisine (E 122).

3. How to take Venlafaxine Retard Sandoz

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

The usual recommended starting dose for the treatment of depression, generalized anxiety disorder, and social anxiety disorder is 75 mg daily. Your doctor may gradually increase your dose and, if necessary, further increase it up to a maximum of 375 mg daily for depression. If you are being treated for panic disorder, your doctor will start with a lower dose (37.5 mg) and then gradually increase the dose. The maximum dose for generalized anxiety disorder, social anxiety disorder, and panic disorder is 225 mg/day.

Take Venlafaxine Retard Sandoz at approximately the same time each day, either in the morning or in the evening. The capsules must be swallowed whole with liquid and must not be opened, crushed, chewed, or dissolved.

Venlafaxine Retard Sandoz should be taken with food.

If you have liver or kidney problems, talk to your doctor, as your dose of this medicine may need to be different.

Do not stop taking this medicine without consulting your doctor (see section “If you stop taking Venlafaxine Retard Sandoz”).

If you take more Venlafaxine Retard Sandoz than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

Overdose can be life-threatening, especially when taken simultaneously with certain medicines and/or alcohol (see “Other medicines and Venlafaxine Retard Sandoz”).

Symptoms of a possible overdose may include palpitations, changes in alertness (ranging from drowsiness to coma), blurred vision, seizures or fits, and vomiting.

If you forget to take Venlafaxine Retard Sandoz

If you have missed a dose, take it as soon as you remember. However, if it is already time for your next dose, skip the missed dose and take only your next dose as usual. Do not take a double dose to make up for forgotten doses. Do not take more than the daily amount of Venlafaxine Retard Sandoz prescribed for you in one day.

If you stop taking Venlafaxine Retard Sandoz

Do not stop taking this medicine or reduce the dose without consulting your doctor, even if you feel better. If your doctor considers that you no longer need Venlafaxine Retard Sandoz, they may instruct you to gradually reduce the dose before stopping treatment completely. Adverse effects are known to occur when people discontinue this medicine, especially if it is stopped suddenly or the dose is reduced too quickly. Some patients may experience symptoms such as suicidal thoughts, aggression, fatigue, dizziness, loss of coordination, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, ringing in the ears, tingling sensations, or, rarely, electric shock-like sensations, weakness, sweating, seizures, flu-like symptoms, vision problems, and increased blood pressure (which may cause headache, dizziness, ringing in the ears, sweating, etc.).

Your doctor will advise you on how to gradually discontinue treatment with Venlafaxine Retard Sandoz. This process may take several weeks or months. In some patients, discontinuation may need to be very gradual over months or longer. If you experience any of these or other bothersome symptoms, consult your doctor for advice.

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

4. Possible adverse effects

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

If any of the following effects occur, stop taking Venlafaxine Retard Sandoz immediately and contact your doctor right away or go to the nearest hospital emergency department:

Uncommon (may affect up to 1 in 100 people)

• Swelling of the face, mouth, tongue, throat, hands or feet and/or swollen, itchy rash, difficulty swallowing or breathing.

Rare (may affect up to 1 in 1,000 people)

• Chest tightness, noisy breathing, difficulty swallowing or breathing,
• severe skin rash, itching or urticaria (raised, red or pale areas of skin that often itch),
• signs and symptoms of serotonin syndrome, which may include agitation, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, hyperactive reflexes, diarrhea, coma, nausea, vomiting.

In its most severe form, serotonin syndrome may resemble neuroleptic malignant syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, increased muscle enzymes (detected by a blood test),

• signs of infection, such as increased temperature, chills, shivering, headache, sweating, or flu-like symptoms. This may be due to a blood disorder that could lead to an increased risk of infection,
• severe rash, which may progress to the formation of severe blisters and skin peeling,
• unexplained muscle pain, tenderness or weakness. This may be a sign of rhabdomyolysis.

Frequency not known (cannot be estimated from available data)

Signs and symptoms of a condition called "stress cardiomyopathy" which may include chest pain, difficulty breathing, dizziness, fainting, or irregular heartbeats.

Other adverse effects you should report to your doctor are (the frequency of these adverse effects are included in the following list “Other adverse effects that may occur”):

• cough, noisy breathing, and difficulty breathing that may be accompanied by increased temperature,
• tar-like stools or blood in stools,
• itching, yellowing of the eyes or skin, dark urine, which are symptoms of liver inflammation (hepatitis),
• heart problems, such as fast or irregular heartbeat, increased blood pressure,
• eye problems, such as blurred vision, dilated pupils,
• nerve problems, such as dizziness, tingling, movement disorders (muscle spasms and stiffness), seizures or fits,
• psychiatric problems, such as hyperactivity (unusual feeling of over-excitement),
• withdrawal syndrome (see section “How to take Venlafaxine Retard Sandoz, if you stop taking Venlafaxine Retard Sandoz”),
• prolonged bleeding, if you get a cut or injury, it may take slightly longer than normal for the bleeding to stop.

Other adverse effects that may occur

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

• Dizziness, headache, drowsiness,
• insomnia,
• nausea, dry mouth, constipation,
• excessive sweating (including night sweats).

Common (may affect up to 1 in 10 people)

• Decreased appetite,
• confusion, feeling strange, absence of orgasm, decreased libido, agitation, restlessness, abnormal dreams,
• tremor, a feeling of restlessness or inability to sit still or remain motionless, tingling, altered taste perception, increased muscle tone,
• visual disturbances including blurred vision, dilated pupils, inability of the eye to automatically adjust focus from distant to near objects,
• ringing in the ears (tinnitus),
• rapid heartbeat, palpitations,
• increased blood pressure, hot flushes,
• difficulty breathing, yawning,
• vomiting, diarrhoea,
• mild skin rash, itching,
• increased frequency of urination, inability to urinate, difficulties in urination,
• menstrual irregularities such as increased bleeding or increased irregular bleeding, abnormal ejaculation/orgasm (in men), erectile dysfunction (impotence),
• weakness (asthenia), fatigue, chills,
• weight gain or weight loss,
• increased cholesterol.

Uncommon (may affect up to 1 in 100 people)

• Hyperactivity, racing thoughts and decreased need for sleep (mania),
• hallucinations, feeling detached from reality, abnormal orgasm, lack of feelings or emotions, feeling overexcited, teeth grinding,
• fainting, involuntary muscle movements, disturbance in coordination and balance,
• feeling dizzy (especially when standing up too quickly), decreased blood pressure,
• vomiting blood, tar-like stools (faeces) or blood in the stools, which may be a sign of internal bleeding,
• sensitivity to sunlight, bruising, abnormal hair loss,
• inability to control urine,
• muscle stiffness, spasms and involuntary muscle movements,
• slight changes in blood levels of liver enzymes.

Rare (may affect up to 1 in 1,000 people)

• Seizures or fits,
• cough, noisy breathing and shortness of breath which may be accompanied by high temperature,
• disorientation and confusion often accompanied by hallucinations (delirium),
• excessive water intake (known as SIADH),
• decreased levels of sodium in the blood,
• severe eye pain and reduced or blurred vision,
• abnormal, fast or irregular heartbeat, which may lead to fainting,
• severe abdominal or back pain (which may indicate a serious problem in the intestine, liver or pancreas),
• itching, yellowing of the eyes or skin, dark urine, flu-like symptoms, which are symptoms of liver inflammation (hepatitis).

Very rare (may affect up to 1 in 10,000 people)

• Prolonged bleeding, which may be due to a reduced number of platelets in the blood leading to an increased risk of bruising or bleeding,
• abnormal production of breast milk,
• unexpected bleeding, for example, bleeding from the gums, blood in urine or vomit, or the appearance of unexpected bruising or broken blood vessels (broken veins).

Frequency not known (cannot be estimated from the available data)

• Suicidal thoughts and suicidal behaviour; cases of suicidal thoughts and behaviour have been reported during treatment with venlafaxine or shortly after discontinuation of treatment (see section 2, “What you need to know before taking Venlafaxine Retard Sandoz”),
• aggression,
• vertigo,
• heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see “Pregnancy” in section 2 for more information.

Venlafaxine Retard Sandoz sometimes causes unwanted effects that you may not be aware of, such as increases in blood pressure or an abnormal heartbeat; slight changes in blood levels of liver enzymes, sodium or cholesterol. Less frequently, Venlafaxine Retard Sandoz may reduce the function of blood platelets, leading to an increased risk of bruising or bleeding. Therefore, your doctor may wish to carry out occasional blood tests, particularly if you have been taking Venlafaxine Retard Sandoz for a long time.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Venlafaxine Retard Sandoz

Keep this medicine out of sight and reach of children.

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

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the container and additional information

Composition of Venlafaxine Retard Sandoz

The active substance is venlafaxine.

Venlafaxine Retard Sandoz 75 mg prolonged-release hard capsules:

• Each prolonged-release hard capsule contains 84.9 mg of venlafaxine hydrochloride, equivalent to 75 mg of venlafaxine.
• The other components are:

Capsule contents: microcrystalline cellulose, povidone (K90 D), talc, colloidal anhydrous silica, magnesium stearate, ethylcellulose and copovidone.

Capsule shell: black iron oxide (E 172), red iron oxide (E 172), titanium dioxide (E 171), gelatin, purified water.

Capsule printing ink: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, concentrated ammonium hydroxide solution, red iron oxide (E 172).

Venlafaxine Retard Sandoz 150 mg prolonged-release hard capsules:

• Each prolonged-release hard capsule contains 169.8 mg of venlafaxine hydrochloride, equivalent to 150 mg of venlafaxine.
• The other components are:

Capsule contents: microcrystalline cellulose, povidone (K90 D), talc, colloidal anhydrous silica, magnesium stearate, ethylcellulose, and copovidone.

Capsule shell: brilliant blue FCF (E 133) (contains sodium), allura red AC (E 129) (contains sodium), orange yellow S (E 110) (contains sodium), titanium dioxide (E 171), gelatin, purified water.

Printing ink for the capsule: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, sodium hydroxide, povidone, titanium dioxide (E 171).

Venlafaxine Retard Sandoz 225 mg prolonged-release hard capsules:

• Each prolonged-release hard capsule contains 254.7 mg of venlafaxine hydrochloride, equivalent to 225 mg of venlafaxine.
• The other components are:

Capsule contents: microcrystalline cellulose, povidone (K90 D), talc, colloidal anhydrous silica, magnesium stearate, ethylcellulose, and copovidone.

Capsule shell: carmoisine (E 122) (contains sodium), titanium dioxide (E 171), gelatin, purified water.

Capsule printing ink: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, concentrated ammonia solution, indigo carmine (E 132).

Appearance of the Product and Contents of the Package

Venlafaxine Retard Sandoz 75 mg prolonged-release hard capsules

Opaque hard gelatin capsules, peach-colored, approximately 19 mm in length, with a thick and thin red radial circular band printed on both the body and the cap.

The capsule is filled with 6 film-coated mini-tablets, white to off-white, round, biconvex, each containing 12.5 mg.

Venlafaxine Retard Sandoz 150 mg prolonged-release hard capsules

Opaque hard gelatin capsules, dark orange-colored, approximately 21 mm in length, with a thick and thin white radial circular band printed on both the body and the cap.

The capsule is filled with 12 film-coated mini-tablets, white to off-white, round, biconvex, each containing 12.5 mg.

Venlafaxine Retard Sandoz 225 mg prolonged-release hard capsules

Opaque hard gelatin capsules, pink-colored, approximately 23 mm in length, with a thick and thin blue radial circular band printed on both the body and the cap.

The capsule is filled with 18 film-coated mini-tablets, white to off-white, round, biconvex, each containing 12.5 mg.

Packaging

Presented in aluminum-PVC/PVDC blister packs, aluminum-PVC/ACLAR blisters, or aluminum-OPA/Alu/PVC blisters (only for 225 mg).

Package sizes

Blister packs containing 7, 10, 12, 14, 20, 28, 30, 50, 56, 60, 90, 98, 100, and 112 (only for 75 mg and 150 mg) prolonged-release hard capsules.

Unit-dose blister packs containing 100 x 1 prolonged-release hard capsules.

Only certain package sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsible Party

Marketing Authorization Holder:

Sandoz Farmacéutica, S.A.

Parque Norte Business Park
Roble Building
C/ Serrano Galvache, 56
28033 Madrid
Spain

Manufacturing Responsible Party:

Lek Pharmaceuticals d.d
Verovškova ulica, 57
1526 Ljubljana
Slovenia

or

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, Sachsen-Anhalt
39179 Barleben
Germany

Date of latest review of this leaflet: August 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/