Package leaflet: Information for the user Tonpular XL 76mg Prolonged-Release Hard Capsules Tonpular XL 160mg Prolonged-Release Hard Capsules

Venlafaxine Hydrochloride

Read all of this 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 further questions, ask your doctor or pharmacist.

-    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Tonpular XL is and what it is used for

2.    What you need to know before you take Tonpular XL

3.    How to take Tonpular XL

4.    Possible side effects

6. How to store Tonpular XL

6. Contents of the pack and other information

1. What Tonpular XL is and what it is used for

Tonpular XL contains the active substance venlafaxine hydrochloride. Tonpular XL is an antidepressant that belongs to a group of medicines called Serotonin and Noradrenaline Reuptake Inhibitors (SNRIs). Everyone has substances in their brain called serotonin and noradrenaline. It is thought that people suffering from depression (and associated conditions) have less of these substances compared to people who do not have depression (and associated conditions). It is not fully understood how antidepressants work, but they may help by increasing the amount of serotonin and noradrenaline in the brain.

Tonpular XL is used to treat:

•    Depression (including anxiety symptoms)

If you are depressed, you may have feelings of extreme sadness. These feelings can interfere with your everyday life and last a long time (e.g. weeks and months).

•    Panic Disorder (panic attacks)

Venlafaxine, which is contained in Tonpular XL, is also authorised to treat other conditions which are not mentioned in this leaflet. Ask your doctor or pharmacist if you have further questions.

2. What you need to know before you take Tonpular XL

Do not take Tonpular XL if:

•    you are allergic (hypersensitive) to venlafaxine hydrochloride or to any of the other ingredients in Tonpular XL (see section 6, Further information)

•    you are taking, or have taken within the last 14 days any medicine called monoamine oxidase inhibitors (MAOIs). These medicines can be used to treat depression or Parkinson's disease. Taking an irreversible MAOI together with other medicines, including Tonpular XL, can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking Tonpular XL before you take any MAOI (see also the sections “Serotonin syndrome” and “Taking other medicines”).

Warning and precautions

Talk to your doctor or pharmacist before taking

Tonpular XL if:

•    you have or have had a history of, or if someone in your family has ever had, mania or bipolar affective disorder (feeling 'high' or over excited alternated with low mood or depression)

•    you have a history of high blood pressure or heart problems

•    you have a history of fits (seizures)

•    you have glaucoma (an increased pressure in the eye)

•    you have increased risk of bleeding or suffer from any bleeding disorders or if you are taking other medicines that may increase the risk of bleeding

•    you have a history of low sodium levels in your blood (hyponatraemia).

•    your cholesterol levels get higher

•    you use other medicines that taken concomitantly with Tonpular XL could increase the risk of developing serotonin syndrome (see the section “Taking other medicines”). Serotonin syndrome can be life-threatening

•    you have a history of aggressive behaviour

•    you have diabetes

Tonpular XL may cause a sensation of restlessness or an inability to sit or stand still. You should tell your doctor if this happens to you.

Do not be concerned if you see small white granules or balls in your stools after taking Tonpular XL. Inside Tonpular XL capsules are spheroids or small white balls that contain the venlafaxine active ingredient. These spheroids are released from the capsule into your gastrointestinal tract. As the spheroids travel the length of your gastrointestinal tract, venlafaxine is slowly released. The spheroid “shell” remains undissolved and is eliminated in your stools. Therefore, even though you may see spheroids in your stools, your dose of venlafaxine has been absorbed.

Use in children and adolescents under 18 years of age

This medicine should not be prescribed for children and adolescents under 18 years of age who have major depressive disorders. This is because the long term effects of Tonpular XL have not yet been established in this age group. It has been found that patients under 18 years of age have an increased risk of experiencing some of the side effects associated with taking Tonpular XL. These side effects include feelings of self harm, thoughts of/or attempted suicide and feelings of hostility (mainly aggression, anger and negative or hostile behaviour). Thoughts of suicide and worsening of your depression or anxiety disorder If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.

You may be more likely to have these kind of thoughts if:

•    you have previously had thoughts about killing or harming yourself

•    you are a young adult. Information from clinical trials has shown an increased risk in suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

If you have thoughts about harming or killing yourself at any time, contact your doctor or go to hospital straight away.

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

Dry mouth

Dry mouth is reported in 10% of patients treated with venlafaxine. This may increase the risk of caries. Therefore, you should take special care in your dental hygiene.

Other medicines and Tonpular XL Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. The following medicines can affect or be affected by treatment with Tonpular XL

•    Monoamine oxidase inhibitors (MAOIs: see the section “Before you take Tonpular XL”)

Serotonin syndrome, a potentially life-threatening condition (see the section “Possible Side Effects”), may occur with venlafaxine treatment, particularly when taken with other medicines.

Examples of these medicines include:

•    triptans (used for migraine)

•    medicines used to treat depression such as SNRI, SSRIs, tricyclics or medicines containing lithium

•    medicines containing linezolid, an antibiotic (used to treat infections)

•    medicines containing moclobemide, a reversible MAOI (used to treat depression)

•    medicines containing sibutramine (used for weight loss)

•    medicines containing tramadol (a pain killer)

•    products containing St. John's Wort (also called Hypericum perforatum, a natural or herbal remedy used to treat mild depression)

•    products containing tryptophan (used for problems such as sleep and depression)

Signs and symptoms of serotonin syndrome may include a combination of the following: restlessness, hallucinations, loss of coordination, fast heart beat, increased body temperature, fast changes in blood pressure, overactive reflexes, diarrhoea, coma, nausea, vomiting, hyperthermia, muscle rigidity, unstable nervous system with possible rapid change in vital signs and mental status. Get medical care right away if you think serotonin syndrome is happening to you.

The following medicines may also interact with Tonpular XL and should be used with caution.

It is especially important to mention to your doctor or pharmacist if you are taking medicines containing:

•    ketoconazole (an antifungal medicine)

•    haloperidol or risperidone (to treat psychiatric conditions)

•    metoprolol (a beta blocker to treat high blood pressure and heart problems)

Diabetes

If you are diabetic and taking venlafaxine, talk to your doctor, as it may alter glycaemic control. Your dosage may need to be adjusted.

Tonpular XL with food and drink Tonpular XL should be taken with food (see section 3 “How to take Tonpular XL”). As with all medicines that act on the central nervous system, alcohol should be avoided while taking this medicine.

Pregnancy and breast-feeding

Tell your doctor if you become pregnant, or you are trying to become pregnant. You should use Tonpular XL only after discussing the potential benefits and the potential risks to your unborn child with your doctor.

If you are taking Tonpular XL during pregnancy, let your midwife and/or doctor know, as your baby might have some symptoms when it is born. These symptoms usually begin during the first 24 hours after the baby is born.

They include not feeding properly and trouble with breathing. If your baby has these symptoms when it is born and you are concerned, contact your doctor and/or midwife who will be able to advise you.

Make sure your midwife and/or doctor know you are on Tonpular XL. When taken during pregnancy, similar drugs (SSRIs) may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the new born (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your midwife and/or doctor immediately.

Tonpular XL passes into breast milk. There is a risk of an effect on the baby. Therefore, you should discuss the matter with your doctor, and he/she will decide whether you should stop breast feeding or stop the therapy with Tonpular XL.

Driving and using machines

It is possible that Tonpular XL may make you feel drowsy. Do not drive or operate machinery if affected.

Tonpular XL 75mg capsules contain sunset yellow FCF (E110), carmoisine (E122) and allura red AC (E129). These azo colouring agents may cause allergic reactions. Tonpular XL 150mg capsules contain sunset yellow FCF (E110) and tartrazine (E102). These azo colouring agents may cause allergic reactions.

3. How to take Tonpular XL

Always take Tonpular XL as your doctor has told you. Your doctor will decide the right dose for you; this will be on the pharmacist's label. Check this carefully, it will tell you how many capsules to take and how often to take them. Do not crush or chew the capsule or any of the pellets. The required dose should be swallowed whole with a glass of water, taken at the same time every day either with evening meal or breakfast. The dose of Tonpular XL depends on your condition:

Treatment of Depression (including anxiety symptoms)

•    one 75mg capsule per day

•    your doctor will monitor your treatment. If there is no improvement in your condition your dose may be increased to 375mg per day.

Panic Disorder

•    one 37.5mg capsule per day which may be increased gradually. The maximum dose is 225mg per day

For elderly patients the dosage should be carefully monitored by your doctor. For patients with moderate kidney and liver problems only half of the above dose should be taken.

If you take more Tonpular XL than you should

If you (or anybody else including a child) take more Tonpular XL than you should, contact your nearest hospital casualty department or doctor immediately. Always take the blister pack of capsules and this leaflet with you. The symptoms of a possible overdose may include a rapid heart beat, changes in level of alertness

(ranging from sleepiness to coma), blurred vision, seizures or fits, muscle deterioration and vomiting.

If you forget to take Tonpular XL If you forget a dose, take another as soon as you remember. If it is almost time for your next dose, then do not take the missed dose at all. NEVER take a double dose to make up for the one missed.

If you stop taking Tonpular XL

Do not stop taking your treatment or reduce the dose without the advice of your doctor even if you feel better. If your doctor thinks that you no longer need Tonpular XL, he/she may ask you to reduce your dose slowly before stopping treatment altogether. Side effects are known to occur when people stop using Tonpular XL especially when Tonpular XL is stopped suddenly or the dose is reduced too quickly. If you suddenly stop taking this medicine you may experience:

Your doctor will advise you on how you should gradually discontinue Tonpular XL treatment.

If you are at all concerned about your treatment or if you have any questions, please speak to your doctor or pharmacist.

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

4. Possible Side Effects

Like all medicines, Tonpular XL can cause side effects, although not everybody gets them.

Allergic reactions

If any of the following happen, do not take more Tonpular XL. Tell your doctor immediately, or go to the casualty department at your nearest hospital:

•    Chest tightness, wheezing, • Swelling of the face, trouble swallowing or breathing throat, hands, or feet

•    Feeling nervous or anxious, • Severe rash, itching, or

dizziness, throbbing sensations, hives (elevated patches sudden reddening of the skin of red or pale skin that and/or a warm feeling    often itch)

Serious side effects

If you notice any signs of the following, you may need

urgent medical attention:

•    Heart problems, such as fast or irregular heart rate, increased blood pressure

•    Nerve problems, such as dizziness, pins and needles, movement disorder, seizures or fits

•    Treatment withdrawal (see the section “How to take Tonpular XL,

Stopping Tonpular XL”).

You should tell your doctor or pharmacist if you have any of the following side effects, or if you think this medicine is making you feel unwell in any other way.

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

•    headache

•    dry mouth; nausea

•    sweating (including night sweats)

Common (may affect up to 1 in 10 people)

•    decreased appetite

•    Abnormal dreams; insomnia; nervousness; confusion; feeling separated (or detached) from yourself and reality); decreased libido; abnormal orgasm (male); lack of orgasm

•    palpitations

•    increase in blood pressure; flushing

•    yawning

•    constipation; vomiting

•    difficulties passing urine; increased frequency in urination

•    abnormal ejaculation erectile dysfunction (impotence); menstrual irregularities such as increased bleeding or increased irregular bleeding

•    weakness (aesthesia); chills

•    increased cholesterol; weight loss

Uncommon (may affect up to 1 in 100 people)

•    lack of feeling or emotion; hallucinations; agitation; grinding of the teeth

•    involuntary movement of the muscles; impaired coordination and balance; altered taste sensation; fainting

•    ringing in the ears (tinnitus)

•    fast heartbeat

•    feeling dizzy (particularly when standing up too quickly);

•    shortness of breath or trouble breathing

•    diarrhoea; black tarry stools (faeces) or blood in stools, which can be a sign of internal bleeding

•    swelling of the skin; rash; abnormal hair loss; bruising; sensitivity to sunlight

•    inability to pass urine

•    abnormal orgasm (females)

•    weight gain

Rare (may affect up to 1 in 1000 people)

•    feeling over excited or euphoric

•    a sensation of restlessness or an inability to sit or stand still; seizures or fits

•    inability to control urination

Not known (frequency cannot be estimated from the

available data)

•    reduced number of platelets in your blood, blood disorders which may lead to an increased risk of infection.

•    decrease in blood sodium levels; confusion

•    euphoric feelings; thoughts of harming or killing yourself; aggression

•    Excessive water intake (known as SIADH)

•    a high temperature with rigid muscles, disorientation and confusion often accompanied by hallucination (delirium); confusion or agitation, and sweating, or if you experience jerky muscle movements which you can't control, these may be symptoms of serious conditions known as neuroleptic malignant syndrome; drowsiness; sustained rapid eye movement; clumsiness; restlessness; feeling of being drunk; sweating or rigid muscles, which are symptoms of serotonergic syndrome; stiffness, spasms and involuntary movements of the muscles

•    severe eye pain; decreased or blurred vision; vertigo (dizziness and balancing trouble when standing up)

•    abnormal, rapid or irregular heartbeat which could lead to fainting

•    decrease in blood pressure

•    coughing; wheezing; shortness of breath and a high temperature, which are symptoms of inflammation of the lungs associated with an increase in white blood cells (pulmonary eosinophilia)

•    severe abdominal or back pains (which could indicate a serious problem in the gut, liver or pancreas

•    itchiness, yellow skin or eyes, dark urine, or flu-like symptoms, which are symptoms of inflammation of the liver (hepatitis)

•    skin rash which may lead to severe blistering and peeling of the skin; itching; mild rash

•    unexplained muscle pain; tenderness or weakness (rhabdomyolysis)

•    bleeding under the skin

•    prolonged bleeding time; abnormal breast milk production; abnormal heartbeat; slight changes in blood levels of liver enzymes

Tonpular XL sometimes causes unwanted effects that you may not be aware of, such as increases in blood pressure or abnormal heart beat; slight changes in blood levels or liver enzymes, sodium or cholesterol. More rarely, Tonpular XL may reduce the function of platelets in your blood, leading to an increased risk of bruising or bleeding. Therefore, your doctor may wish to do blood tests occasionally, particularly if you have been taking Tonpular XL for a long time.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting systems listed below.

United Kingdom Yellow Card Scheme www.mhra.gov.uk/yellowcard Ireland

HPRA Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

e-mail:medsafety@hpra.ie

Malta

ADR Reporting

www.medicinesauthority.gov.mt/adrportal By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Tonpular XL

•    Keep this medicine out of the sight and reach of children.

•    Do not use this medicine after the expiry date which is stated on the blister pack and carton. The expiry date refers to the last day of that month.

•    Store below 25°C. Store in the original package to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Tonpular XL contains

The active ingredient is venlafaxine: Each prolonged

release hard capsule contains 84.8mg of venlafaxine

hydrochloride, equivalent to 75mg venlafaxine or

169.7mg venlafaxine hydrochloride, equivalent to 150mg

venlafaxine.

The other ingredients are:

Contents of the capsule: microcrystalline cellulose, povidone K 30, ethylcellulose, triethyl citrate, talc, methacrylic acid copolymer Type C, sodium bicarbonate, colloidal anhydrous silica, sodium laurilsulfate

Capsule shell: titanium dioxide (E171), sunset yellow FCF (E110), brilliant blue FCF (E133), gelatin, sodium laurilsulfate, shellac.

75mg strength capsule shell also contain: carmoisine (E122), povidone and allura red (E129).

150mg strength capsule shell also contain: tartrazine (E102).

What Tonpular XL look like and the contents of the pack

Tonpular XL 75mg Prolonged-Release Hard Capsules

are a hard gelatine capsule with light pink opaque cap and light pink opaque body filled with white to off white pellets, imprinted with ^W7 on cap in red colour.

Tonpular XL 150mg Prolonged-Release Hard Capsules are a hard gelatine capsule with orange opaque cap and orange opaque body filled with white to off white pellets, imprinted with W₈ on cap in white colour.

Both strengths are supplied in a blister pack and outer cardboard carton, and are available in pack size of 14 or 28 capsules. Not all pack sizes may be marketed. Marketing Authorisation Holder: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK. Manufacturer: CP Pharmaceuticals Ltd, Ash Road North, Wrexham LL13 9UF, UK. These medicinal products are authorised in the Member States of the EEA under the following names:

UK: Tonpular XL 75mg or 150mg Prolonged-Release Hard Capsules

Ireland: Tonpular XL 75mg or 150mg Prolonged-Release Hard Capsules

Poland: Tonpular XL 75mg or Tonpular XL 150mg Cyprus: Tonpular XL 75mg or 150mg Prolonged-Release Hard Capsules

Malta: Tonpular XL 75mg or 150mg Prolonged-Release Hard Capsules Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only).

Please be ready to give the following information:

Product name	Reference number
Tonpular XL 75mg Prolonged-Release Hard Capsules	29831/0364
Tonpular XL 150mg Prolonged-Release Hard Capsules	29831/0365

This is a service provided by the Royal National Institute of Blind People

For the Republic of Ireland please call +44 1978 669272 This leaflet was last revised in 03/2016

^WOCKHARDT