Lantus SoloStar 5 pens of 3 ml

Lantus SoloStar 5 pens of 3 ml

Composition:

Each pen contains 3 ml of solution for

injection (equivalent to 300 units).

Each ml of the solution contains:

Insulin glargine 100 Units (equivalent to 3.64 mg).

Inactive ingredients: zinc chloride,

metacresol, glycerol, sodium hydroxide, water for injections.

Properties:

Lantus contains insulin glargine. This is a modified insulin, very similar to human insulin. Lantus is used to treat diabetes mellitus in adults, adolescents and children aged 2 years and above. Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of blood sugar. 

Insulin glargine has a long and steady blood-sugar-lowering action.

Indications:

LANTUS is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

Dosage and administration:

Always use this medicine exactly as your doctor has told you. 

Your doctor will determine how much Lantus per day you will need and at what time.

Lantus is a long-acting insulin. Your doctor may tell you to use it in combination with a

short-acting insulin or with tablets used to treat high blood sugar levels.

• Use in children and adolescents:

Lantus can be used in adolescents and

children aged 2 years and above. Use this

medicine exactly as your doctor has told you.

• You need one injection of Lantus every day, at the same time of the day.

A new needle must be attached before each use. 

A safety test must be performed before each injection.

Only use the pen if the solution is clear,

colorless and waterlike. Do not shake or mix it before use.

Always use a new pen if you notice that your blood sugar control is unexpectedly getting worse. 

• You must always check the insulin label before each injection to avoid mix-ups

 Lantus and other insulins.

• If you use more Lantus than you should:

– If you have injected too much Lantus, your blood sugar level may become too low (hypoglycaemia). Check your blood sugar frequently. In general, to prevent hypoglycaemia you must eat more food and monitor your blood sugar. 

If you forget to use Lantus:

– If you have missed a dose of Lantus or if you have not injected enough insulin, your blood sugar level may become too high (hyperglycaemia). Check your blood sugar frequently. Do not take a double dose to make up for a forgotten dose.

• Do not stop Lantus without speaking to a doctor, who will tell you what needs to be done.

Side effects:

Serious: hypoglycaemia( may cause brain damage and may be life-threatening). 

Rare: rash and itching all over the body, severe swelling of skin or mucous membranes (angioedema), shortness of breath, a fall in blood pressure with rapid heartbeat and sweating, lumps under the skin.

Common: Skin and allergic reactions at the injection site

Rare: Eye reactions, temporary loss of vision.

General:

In rare cases, insulin treatment may also

cause temporary build-up of water in the

body, with swelling in the calves and ankles.

Very rare: dysgeusia (taste disorders)

and myalgia (muscular pain) 

Contraindications:

– If you are allergic to insulin glargine or to any of the other ingredients of this medicine. 

Warnings and precautions:

• Lantus in pre-filled pen is only suitable

for injecting just under the skin. Speak to your doctor if you need to inject your insulin by another method.

• The injection site should be rotated to prevent skin changes such as lumps under

the skin. The insulin may not work very well if you inject into a lumpy area. 

• Before traveling consult your doctor. You may need to talk about:

– the availability of your insulin in the country you are visiting,

– supplies of insulin, needles etc.,

• Inform your doctor as soon as possible if

you experience signs of heart failure such as unusual shortness of breath, or rapid increase in weight, or localized swelling (oedema).

• Medicines that may cause your blood sugar level to rise (hyperglycaemia) include: corticosteroids, danazol (medicine acting on ovulation), diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens, phenothiazine derivatives, somatropin, epinephrine [adrenaline], salbutamol, terbutaline, thyroid hormones, atypical antipsychotic medicines (such as clozapine, olanzapine)

• Your blood sugar level may either rise or fall if you take: beta-blockers, clonidine, lithium salts (used to treat psychiatric disorders), pentamidine
• Lantus with alcohol:

Your blood sugar levels may either rise or fall if you drink alcohol.

• Pregnancy and breast-feeding:

Inform your doctor if you are planning to

become pregnant, or if you are already

pregnant. Your insulin dose may need to be changed during pregnancy and after giving birth. Particularly careful control of your diabetes and prevention of hypoglycaemia, is important for the health of your baby. If you are breast-feeding consult your doctor as you may require adjustments in your insulin doses and your diet.

• Driving and using machines:

Your ability to concentrate or react may be reduced if:

-you have hypoglycemia (low blood sugar

levels),

-you have hyperglycemia (high blood sugar levels),

– you have problems with your sight.

• There is no experience in children under 2 years.
• Keep this medicine out of the sight and reach of children.

Storage:

• Not in-use pens:

Store in a refrigerator (2°C-8°). Do not freeze or place next to the freezer compartment or a freezer pack.

Keep the pre-filled pen in the outer carton in order to protect from light.

• In-use pens:

Pre-filled pens in use or carried as a spare may be stored for a maximum of 4 weeks not above 30°C and away from direct heat or direct light. The pen in use must not be stored in the refrigerator. Do not use it after this time period.

Package:

Carton box holds 5 pens of 3 ml, paper instructions