Teratyde Solution

TERATYDE contains the active substance teriparatide. It is used to make the bones stronger, and to reduce the risk of fractures by stimulating bone formation. TERATYDE is used to treat osteoporosis in adults. Osteoporosis is a disease that causes your bones to become weak and thus making them fragile. This disease is especially common in women after menopause, but it can also occur in men. Osteoporosis is also common in patients receiving corticosteroids.

Do not use TERATYDE:

• if you are hypersensitive (allergic) to teriparatide or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from high calcium levels;
• if you have high levels of an enzyme, alkaline phosphatase;
• if you have certain bone diseases;
• if you have ever been diagnosed with bone cancer or other cancers that have spread to your bones;
• if you have had radiation therapy involving your bones;
• if you are pregnant or breast-feeding;
• if you suffer from serious kidney problems.

Warnings and precautions

Take special care with TERATYDE:

• if you have continuous nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs of too much calcium in your blood;
• if you are a woman of childbearing potential. You should make use of an effective method of contraception;
• if you are premenopausal women;
• if you suffer from kidney stones or have a history of kidney stones;
• if you suffer from any kidney problems.
• If you experience a drop in blood pressure when standing up, it is advised to receive TERATYDE in a laying down position for the first several doses. Monitor calcium levels in blood regularly during treatment with TERATYDE.

Children and adolescents

TERATYDE should not be given to children below 18 years of age.

Other medicines and TERATYDE

Always tell your health care provider if you are taking any other medicine (This includes all complementary or traditional medicines)

• Tell your healthcare provider if you are taking digoxin/digitalis, a medicine used to treat heart disease.

Pregnancy, breast-feeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking this medicine.

Pregnancy: Do not use TERATYDE if you are pregnant. If you are a woman of child-bearing potential, you should use effective methods of contraception during use of TERATYDE.

Breastfeeding: Do not use TERATYDE while you are breastfeeding.

Do not share medicines prescribed for you with any other person. Always use TERATYDE exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is 20 micrograms given once daily by injection under the skin (subcutaneous injection) in the thigh or abdomen. To help you remember to use your medicine, inject it at about the same time each day.

Inject TERATYDE each day for as long as your doctor prescribes it for you. The total duration of treatment with TERATYDE should not exceed 24 months. You should not receive more than one treatment course of 24 months over your lifetime.

You should use TERATYDE injection shortly after you take the pen out of the refrigerator. Put the pen back into the refrigerator immediately after you have used it. Use a new injection needle for each injection and dispose of it after each use. Never store your pen with the needle attached. Never share your TERATYDE pen with others even if the needle is changed.

Your doctor may advise you to use TERATYDE with calcium and vitamin D. Your doctor will tell you how much you should use each day. TERATYDE can be injected at mealtimes.

If you use more TERATYDE than you should If by mistake, you have used more TERATYDE than you should, consult your doctor or pharmacist. You may experience effects such as nausea, vomiting, dizziness, and headache.

If you forget to use TERATYDE If you forget to use TERATYDE at your usual time, use it as soon as possible on that day. Do not use a double dose to make up for forgotten individual doses.

If you stop using TERATYDE If you are considering stopping TERATYDE treatment, please discuss this with your doctor. Your doctor will advise you and decide how long you should be treated with TERATYDE. If you have any further questions on the use of this product, ask your doctor or pharmacist.

TERATYDE can have side effects. Not all side effects reported for TERATYDE are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking TERATYDE, please consult your doctor, pharmacist or other healthcare provider for advice.

If any of the following happens, stop taking TERATYDE and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Anaphylaxis (sudden life threatening allergic reaction. Symptoms include rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing);
• Possible allergic reactions soon after injection: swelling of mouth and face, hands, ankles or feet, hives, chest pain, peripheral oedema (swelling due to retained fluid). These are very serious side effects. If you have them, you may have had a serious reaction to TERATYDE. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Fast or irregular heartbeats;
• Chest pain;
• Cardiac murmur (heart murmur. Blowing, whooshing, or rasping sound heard during a heartbeat);
• Dyspnoea (difficulty breathing or shortness of breath);
• Emphysema (serious lung disease that makes breathing difficult. Symptoms include shortness of breath with cough);
• Kidney failure (symptoms may include decreased urinary output, swelling due to fluid retention, nausea, fatigue and shortness of breath). These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Anaemia (decreased number of red blood cells. Symptoms may include tiredness, headaches, being short of breath when exercising, dizziness and looking pale);
• Increased cholesterol levels in blood;
• Depression;
• Headache;
• Dizziness, fainting;
• Pain radiating along the sciatic nerve, which runs down one or both legs from the lower back;
• Palpitations (Rapid irregular action of the heart);
• Low blood pressure. Symptoms may include feeling dizzy, confusion, cold skin, rapid and shallow breathing;
• Nausea, vomiting;
• Hernia of the tube that carries food to your stomach;
• Heartburn (painful or burning sensation just below the breastbone);
• Increased sweating;
• Pain in limb;
• Muscle cramps;
• Tiredness, unusual weakness, injection site events including pain, swelling, redness, localised bruising, itching and minor bleeding.

Less frequent side effects:

• High calcium levels in blood. Symptoms may include loss of appetite, nausea, vomiting, constipation, stomach pain;
• High uric acid levels in blood. Symptoms may include severe pain in your joints, joint stiffness, difficulty moving affected joints, redness and swelling of joints;
• Piles;
• Muscle pain, joint pain, back pain;
• Loss of bladder control;
• Kidney stones;
• Weight increased;
• Increased level of an enzyme, alkaline phosphatase in blood.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects If you get side effects, talk to your doctor or pharmacist or nurses. This includes any possible side effects not listed in this leaflet. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of TERATYDE.

Suspected adverse reactions can also be reported directly to the Holder of Certificate of Registration (HCR) via email: [email protected] or tel: +27(0) 12 643 2000

Store all medicines out of reach of children. Store in a refrigerator between 2 °C and 8 °C. Do not freeze. Do not use TERATYDE if it has been frozen. The TERATYDE prefilled delivery device should be discarded 28 days after the first injection from the device, even if there is solution left in the pen.