Mental Health

“Mental health is a sickness just like diabetes and heart problems.”

- Betty Jordan

Antidepressants

SSRI’s

Serrapress

SCHEDULING STATUS S5

PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
SERRAPRESS 20 (Tablets)

Please read thiinformation carefully before using SERRAPRESS

  • Keep thiinformation.  You may need to read it again.
  • If you have any further questions, please ask your doctor or your pharmacist.
  • SERRAPRESS has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours.

WHAT SERRAPRESS CONTAINS

Active ingredient:  Paroxetine

Inactive ingredients:  Magnesium stearate, sodium starch glycollate, DMannitol, Micorocrystalline Cellulose, Eudragit, Opadry AMB White

WHAT SERRAPRESS IS USED FOR:

SERRAPRESS is used to treat a variety of emotional problems. It can be prescribed for serious, continuing depression that interferes with your ability to function. Symptoms of this type of depression often include changes in appetite and sleep patterns, a persistent low mood, loss of interest in people and activities, decreased sex drive, feelings of guilt or worthlessness, suicidal thoughts, difficulty concentrating and slowed thinking.

SERRAPRESS is also used to treat obsessive compulsive disorder (OCD). A condition

marked by unwanted, but stubbornly persistent thoughts, or unreasonable rituals you feel compelled to repeat.

SERRAPRESS can be used in the treatment of social anxiety disorder (also known as social phobia), a condition marked by shyness or stage fright so intense that it interferes with your work and social life.

In addition, SERRAPRESS is prescribed for panic disorder, a crippling emotional problem characterised by sudden attacks of at least four of the following symptoms: palpitations, sweating, shaking, numbness, chills or hot flashes, shortness of breath, a feeling of choking, chest pain, nausea or abdominal distress, dizziness or faintness, feelings of unreality or detachment, fear of losing control, or fear of dying.

SERRAPRESS can be prescribed for generalised anxiety disorder, a disease marked by excessive anxiety and worry that persists for at least 6 months and cannot be easily controlled. True cases of generalised anxiety disorder are accompanied by at least three of the following symptoms: restlessness or a keyedup or onedge feeling, a tendency to wear out easily, difficulty concentrating or spells when the mind goes blank, irritability, muscle tension, or sleep disturbance.

BEFORE YOU USE SERRAPRESS

Do not take SERRAPRESS:

  • If you are allergic (hypersensitive) to paroxetine, other selective serotonin reuptake inhibitors or to any of the ingredients in this formulation (see WHAT SERRAPRESS CONTAINS).
  • If you are taking medicines called monoamine oxidase inhibitors (MAOls, including moclobemide), or have taken them at any time within the last two weeks. Your doctor will advise you how you should begin taking SERRAPRESS once you have stopped taking the MAOI.
  • SERRAPRESS should not be used for children and adolescents under the age of 18 years.
  • If you are taking a tranquilliser called thioridazine.
  • If you have epilepsy or a history of seizures / fits.

Take special care with SERRAPRESS:

  • If you have any suicidal thoughts, especially in the beginning of treatment, consult your doctor immediately
  • Do not stop taking SERRAPRESS without talking to your doctor. If you stop taking your SERRAPRESS tablets suddenly, you may experience withdrawal effects (see POSSIBLE SIDE EFFECTS).
  • If you have episodes of mania (overactive behaviour or thoughts).
  • If you have a history of bleeding disorders.
  • Do not consume alcohol while using SERRAPRESS.
  • If you have a heart disorder.
  • If you have high pressure within the eye (glaucoma).
  • If you have high levels of sugar in your blood (diabetes).

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 take time to work, (usually about two weeks but sometimes longer).

You may be more likely to think like this if you

  • Have previously had thoughts about killing or harming yourself
  • Are a young adult. Information from clinical trials has shown an increase risk of suicidal behaviour in young adults (less than 25 years old) with psychiatric conditions who were treated with antidepressants
  • If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.

Children and adolescents under 18
Paroxetine should not be used for children and adolescents under 18 years. Patients under
18 have an increased risk of side effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger)when they take SERRAPRESS. If your doctor has prescribed SERRAPRESS for you (or your child) and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen when you (or your child) are taking SERRAPRESS. The longterm safety effects concerning growth, maturation and cognitive and behavioural development of SERRAPRESS in this age group have not yet been demonstrated in studies of SERRAPRESS in under 18s, common side effects that affected less than 1 in 10 children/adolescents were: an increase in suicidal thoughts and suicide attempts, deliberately harming themselves, being hostile, aggressive or unfriendly, lack of appetite, shaking, abnormal sweating, hyperactivity (having too much energy), agitation, changing emotions (including crying and changes in mood) and unusual bruising or bleeding (such as nose bleeds).

These studies also showed that the same symptoms affected children and adolescents taking sugar pills (placebo) instead of Paroxetine, although these were seen less often. Some patients in these studies of under 18s had withdrawal effects when they stopped taking Paroxetine. In addition patients under 18 also commonly experienced stomach ache, feeling nervous and changing emotions (including crying, changes in mood, trying to hurt themselves, thoughts of suicide and attempting suicide).

You may find it helpful to tell a relative or close friend 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.

Taking SERRAPRESS with food or drink:
SERRAPRESS should be taken once a day in the morning with food. Do not drink alcohol while you are taking SERRAPRESS. Alcohol may worsen your side effects.

Pregnancy and breast feeding:
The safe use of SERRAPRESS during pregnancy and breastfeeding has not been established. If you are pregnant, suspect that you are pregnant or breastfeeding your baby, consult your doctor immediately.

If you are planning to become pregnant or are breastfeeding ask you doctor or pharmacist for advice before taking this medication. If you are already taking SERRAPRESS and have just found out that you are pregnant you should talk to your doctor immediately. This is because some studies have suggested an increase in the risk of heart defects in babies whose mothers received paroxetine in the first few months of pregnancy.

You and your doctor may decide that it is better for you to gradually stop taking SERRAPRESS while you are pregnant. However, depending on your circumstances, your doctor may suggest that it is better for you to keep taking SERRAPRESS.

When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines likSERRAPRESS may increase the risk of serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN). PPHN increases blood pressure in the blood vessels in the lungs. This may result in abnormal blood flow to the lungs and heart and the baby cannot get enough oxygen into their blood stream. These symptoms usually begin during the fist 24 hours after birth and include not being able to sleep or feed properlybreathing faster, a blueish skin or being too hot or cold, being sick, crying a lot, stiff or floppy muscles, lethargy, tremors, jitters or fits. If your baby has any of these symptoms when it is born and you are concerned, contact your doctor or midwife who will be able to advise you.

Driving and using machinery:
SERRAPRESS may cause drowsiness and dizziness. Make sure you know how you react to SERRAPRESS before driving a vehicle, operating machinery, or do anything else that could be dangerous.

Using other medicines with SERRAPRESS:
Consult your doctor, pharmacist or healthcare professional for advice if you need to take any other medicines. If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of SERRAPRESS with these medicinemay cause undesirable interactions.

The following medicines should not be used in combination with SERRAPRESS:

  • Cimetidine (used to treat heart burn)
  • Phenytoin or phenobarbital (used in the treatment of epilepsy)
  • Digoxin (used in the treatment of heart failure)
  • Tricyclic antidepressants such as amitriptyline, imipramine (used to treat depression)
  • Risperidone (used to treat psychiatric conditions)
  • Lithium (used to treat depression)
  • Aspirin, ibuprofen or other medicines called NSAIDs (nonsteroidal anti inflammatordrugs) used for pain and inflammation.
  • Sumatriptan (used to treat migraine)
  • Theophylline (used in the treatment of asthma)

PROPER USE OF THIS MEDICATION

SERRAPRESS should be taken once a day in the morning with food. However, if your doctor tells you to take SERRAPRESS in a certain way, take it exactly as directed.

Your doctor will advise you what dose to take when you first start taking SERRAPRESS tablets. Most people start to feel better after a couple of weeks. If you do not start to feel better after this time, talk to your doctor for advice.

Your doctor may decide to increase the dose gradually, (10 mg at a time) up to a maximum daily dose.

If you have any questions about the proper dose of SERRAPRESS, ask your doctor or pharmacist.

If you take more SERRAPRESS than you should:
In the event of an overdosage, contact your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre as soon as possible. Take this leaflet and any remaining tablets with you, so that your doctor knows what you have taken.

If you forget to take your SERRAPRESS:
Take the missed dose as soon as possible. However, if it is almost time for your next dose, continue to take the next tablet at the usual time. Do not take a double dose.

POSSIBLE SIDE-EFFECTS

SERRAPRESS may have sideeffects.

Not all side effects reported for SERRAPRESS are included in this leaflet.

Should your general health worsen while taking SERRAPRESS, please consult your doctor, pharmacist or other health care professional for advice.

If any of the following symptoms of an allergic reaction occur, seek medical help as soon as possible:

  • Skin rash, redness of the skin, difficulty in breathing, diarrhoea, dizziness

Common side effects of SERRAPRESS may include:

  • Increased or decreased appetite
  • Not sleeping well (insomnia) or feeling sleepy
  • Feeling dizzy or shaky (tremors)
  • Headache
  • Yawning, dry mouth
  • Diarrhoea or constipation
  • Nausea, vomiting
  • Heart burn, stomach pain, feeling bloated
  • Excessive sweating
  • Decreased sexual ability
  • Unusual tiredness or weakness

Uncommon side effects of SERRAPRESS may include:

  • Abnormal bleeding of the skin
  • Feeling confused
  • Having hallucinations (strange visions or sounds)
  • Memory loss, impaired concentration
  • Absence of or decrease in body movements
  • Migraine (very sever headache)
  • Blurred or abnormal vision
  • Fast irregular heartbeat
  • High or low blood pressure
  • Chest pain, difficulty in breathing, runny nose
  • Skin rashes, sensitivity to sunlight
  • Muscle pain or weakness

Other possible side effects:
Bone fractures, suicidal ideation and suicidal behaviour.

The following side effects may occur on discontinuation of SERRAPRESS treatment: Feeling dizzy or shaky (tremors), sleep disturbances, anxiety, headache, nausea, feeling confused, excessive sweating, diarrhoea.

STORAGE AND DISPOSAL OF SERRAPRESS

  • Store below 25°C. Protect from light.
  • KEEP ALL MEDICINES OUT OF REACH AND SIGHT OF CHILDREN.
  • Do not use after the expiry date printed on the label or carton.
  • Return all unused medicine to your pharmacist.
  • Do not dispose unused medicine in drains and sewerage systems (e.g. toilets).

PRESENTATION OF SERRAPRESS

Aluminium blister packs of 30 tablets. Each blister strip contains 10 tablets.

White cylindrical polypropylene homopolymer tube with a white natural LDPE cap, containin30 tablets.

 

IDENTIFICATION OF SERRAPRESS SERRAPRESS 20:

White to off-white, round, coated, biconvex tablets, diameter 10 mm, scored on both walls and sides. Marked P on one wall and20 on the other wall.

REGISTRATION NUMBERS

 SERRAPRESS 20:
RSA S5 38/1.2/0069
NAM NS3 08/1.2/0101

NAME AND ADDRESSOF REGISTRATION HOLDER

Pharma Dynamics (Pty) Ltd.
F02
Grapevine House
Steenberg
Office Park
WESTLAKE
7945

DATE OF PUBLICATION

September 2009
Version: PD9054A

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